Non-Small Cell Lung Cancer
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Oct 12 – Oct 19, 2026
Anti-TNFR2 antibody BI-1808 induces tumor regression and antitumor T cell immunity through T reg and myeloid cell modulation in patients with solid tumors.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This study clinically evaluated the safety, pharmacodynamic biomarkers, and efficacy of BI-1808, a first-in-class anti-TNFR2 antibody, as a novel immunotherapy for solid tumors. Preclinical modeling informed a first-in-human phase 1 dose-escalation trial in patients with solid cancers. BI-1808 was safe and well-tolerated, achieved full receptor occupancy, and induced tumor regression in two patients (non-small cell lung cancer and gastrointestinal sarcoma), with stable disease in 6 of 21 evaluable patients. Pharmacodynamic analyses confirmed dose-dependent regulatory T cell reduction, monocyte activation, and CD8+ T-cell activation, supporting further development of this mechanistically distinct immunotherapy.
10.1158/1078-0432.CCR-26-2049
Oct 05 – Oct 12, 2026
FIND: a phase-II study to evaluate the efficacy and safety of erdafitinib in FGFR-altered NSCLC.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase-II trial evaluated erdafitinib, a selective FGFR1-4 inhibitor, in patients with FGFR-altered non-small cell lung cancer (NSCLC). Patients were screened within the national Network Genomic Medicine and assigned to three cohorts: high-confidence FGFR fusions, high-confidence FGFR mutations, and low-confidence FGFR alterations, with the primary endpoint of best confirmed overall response rate (ORR) in cohorts 1 and 2 using Simon’s two-stage design. Among 44,537 screened patients, 26 were enrolled and 22 treated (7 in cohort 1, 8 in cohort 2, 7 in cohort 3). In cohort 1, two of seven patients achieved partial response (one unconfirmed), while cohort 2 showed only stable disease as best response; common adverse events included hyperphosphatemia (45.5%), diarrhea (31.8%), and dry mouth (31.8%). The authors conclude that erdafitinib showed preliminary efficacy in FGFR-fusion-positive NSCLC, but further data are needed, especially for FGFR mutations.
10.1158/1078-0432.CCR-26-1485
Canakinumab with chemoradiation and durvalumab consolidation in unresectable stage III non-small cell lung cancer: the phase I/II CHORUS trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
The CHORUS trial (NCT04905316) was an open-label, non-randomized, single-arm phase I/II study evaluating canakinumab, an anti-IL-1beta monoclonal antibody, combined with concurrent chemoradiotherapy followed by durvalumab consolidation in 41 patients with unresectable stage III non-small cell lung cancer. The primary endpoint of 24-month progression-free survival was met at 67% (95% CI, 52-88), exceeding the prespecified historical benchmark of 46%, with 12- and 24-month overall survival rates of 93% and 73%, respectively, and a confirmed objective response rate of 81%. Grade 3-4 canakinumab-related adverse events included neutropenia (n=5), febrile neutropenia (n=1), lymphopenia (n=1), lung infection (n=1), fatigue (n=1), and hypertension (n=1), with no treatment-related deaths; pneumonitis occurred in 24% of patients. The authors conclude these findings support randomized evaluation of interleukin-1beta blockade in this clinical setting.
10.1038/s41467-026-77415-1
Type II ROS1 Inhibition Overcomes Type I Inhibitor Resistance in ROS1 Fusion-Positive Lung Cancers: A Phase II Trial of Cabozantinib.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This single-center, open-label, phase 2 trial evaluated cabozantinib, a type II ROS1/MET tyrosine kinase inhibitor, in 7 patients with pre-treated ROS1 fusion-positive NSCLC enrolled in the first stage of a Simon two-stage design. The primary endpoint was overall response rate, with secondary endpoints of progression-free survival, overall survival, and safety. The ORR was 43% (95% CI, 10-81.5%), including partial responses in patients with ROS1 D2033N and G2032R/L2086F mutations, with median PFS of 4.5 months (95% CI, 4-NE), median duration of response of 8.0 months (range 3-13), and median OS of 11 months (95% CI, 6-NE). Grade 3 treatment-related adverse events occurred in 57%, all patients required dose reduction, and resistance mechanisms included MET overexpression and MET D1228N, supporting type II ROS1 inhibition as a strategy to overcome type I inhibitor resistance.
10.1158/1078-0432.CCR-26-2860
Sep 28 – Oct 05, 2026
Prolonged survival after systemic immune reactivation by aglatimagene besadenovec plus valacyclovir in immune checkpoint inhibitor-refractory non-small cell lung cancer.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This open-label, single-arm phase 2a trial evaluated aglatimagene besadenovec plus valacyclovir in 76 patients with immune checkpoint inhibitor-refractory non-small cell lung cancer. Among 46 evaluable patients completing treatment and week-12 imaging, median overall survival was 24.5 months, with a 10.9% objective response rate and 71.7% disease control rate. Safety analysis of 73 treated patients showed median OS of 14.3 months, no grade 4 treatment-related events, and 13.7% grade 3 events. The authors conclude the regimen induces systemic immune reactivation with encouraging survival, but efficacy requires randomized confirmation.
10.1136/jitc-2026-015821
Sep 21 – Sep 28, 2026
AdvanTIG-105: a phase I/Ib dose-expansion study of ociperlimab plus tislelizumab with or without chemotherapy in metastatic non-small cell lung cancer and extensive-stage small cell lung cancer.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This phase I/Ib dose-expansion trial evaluated ociperlimab plus tislelizumab with or without chemotherapy in patients with metastatic NSCLC or ES-SCLC. The study enrolled 198 patients across five cohorts: untreated sqNSCLC (n=41), untreated non-sqNSCLC (n=43), untreated PD-L1+ NSCLC (n=45), checkpoint inhibitor-experienced NSCLC (n=26), and untreated ES-SCLC (n=43). Objective response rates ranged from 7.7% to 65.9%, with median progression-free survival between 2.9 and 11.3 months, while treatment-related Grade 3-4 adverse events occurred in 20.0% to 60.5% of patients. The combination demonstrated manageable safety and preliminary antitumor activity, though findings from this small phase I study should be interpreted with caution.
10.1136/jitc-2026-015474
Artificial intelligence-enabled early intracranial volumetric response predicts systemic progression-free survival in the phase III CROWN study.
NEURO-ONCOL ADV · Q1 JOURNAL - RANK #50/285
This study utilized data from the phase III CROWN trial to evaluate an FDA-cleared AI platform for automated intracranial response assessment in ALK-positive NSCLC patients with brain metastases. The AI platform demonstrated high concordance with neuroradiologists and identified that AI-based early tumor response (AI-ETR) significantly stratified systemic progression-free survival (adjusted HR 0.44), whereas mRECIST-based response did not. Adding AI-ETR improved prediction over a clinical base model, with an AUC increase of 0.07. The authors conclude that volumetric AI assessment offers early prognostic information beyond standard target-lesion measurements.
10.1093/noajnl/vdag236
Perioperative Pembrolizumab in Japanese Participants With Early-Stage NSCLC: Subgroup Analysis From KEYNOTE-671.
JTO CLIN RES REP · Q1 JOURNAL - RANK #26/108
This subgroup analysis of the phase 3 KEYNOTE-671 trial evaluated perioperative pembrolizumab plus neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in 82 Japanese participants with early-stage NSCLC, randomized 1:1 to pembrolizumab (n=39) or placebo (n=43) plus cisplatin-based chemotherapy for up to 4 neoadjuvant cycles followed by surgery and adjuvant pembrolizumab/placebo for up to 13 cycles. At 48 months, EFS rates were 60.3% versus 39.2% (HR 0.54, 95% CI 0.29-1.02), and OS rates were 79.5% versus 68.9% (HR 0.76, 95% CI 0.33-1.78). Grade 3+ treatment-related adverse events occurred in 59% versus 47%, with no treatment-related deaths. Perioperative pembrolizumab improved efficacy with manageable safety in Japanese patients with early-stage NSCLC.
10.1016/j.jtocrr.2026.101009
Efbemalenograstim alfa as prophylaxis for chemotherapy-induced neutropenia in patients with non-small-cell lung cancer: a randomized, multicenter, phase II trial.
CANCER BIOL MED · Q1 JOURNAL - RANK #20/195
This multicenter, randomized phase II trial evaluated efbemalenograstim alfa (EFBGα) as primary versus secondary prophylaxis for chemotherapy-induced neutropenia in chemotherapy-naïve patients with stage IIIB/IV non-small-cell lung cancer receiving platinum-taxane chemotherapy. Patients were randomized 2:1 to primary prophylaxis (EFBGα 20 mg 48±4 h after each cycle; n=63) or secondary prophylaxis (given only after grade 3-4 neutropenia; n=33), with cycle 1 grade 3-4 neutropenia incidence as the primary endpoint. Primary prophylaxis significantly reduced cycle 1 grade 3-4 neutropenia versus secondary prophylaxis (20.6% vs 57.6%; risk difference -36.9%, 95% CI -52.4% to -16.1%; p<0.001), while median neutropenia duration (p=0.144), cycle 1 FN incidence (1.6% vs 6.1%), and mostly grade 1-2 adverse events (pain-related 7.0%) were comparable. The authors conclude EFBGα shows promising efficacy and tolerability, supporting its use in both prophylactic strategies with earlier initiation yielding better CIN control.
10.20892/j.issn.2095-3941.2026.0311
Induction and concurrent aumolertinib with radiotherapy for EGFR-mutated stage III NSCLC: results of phase III ADVANCE trial and real-world validation.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
The phase III ADVANCE trial prospectively evaluated induction and concurrent aumolertinib with definitive radiotherapy versus cisplatin/pemetrexed with radiotherapy in unresectable stage III EGFR-mutated NSCLC, randomizing 43 patients (24 experimental, 19 control). The trial terminated early due to loss of equipoise, slow accrual, and a large PFS difference observed at interim analysis. At median follow-up of 25.5 months, the experimental arm demonstrated significantly longer PFS (median 34.0 vs. 7.4 months; HR 0.15; P<0.001), with median OS not reached versus 30.5 months (HR=0.32; P=0.09). The authors conclude that the chemo-free TKI plus radiotherapy strategy prolongs PFS and shows promising OS in this population, with real-world validation (n=125) supporting these findings.
10.1038/s41392-026-02891-2
Sep 14 – Sep 21, 2026
Evaluation of MET Detection Methods and Cutoffs in EGFR-Mutated Non-small Cell Lung Cancer Following Disease Progression on Osimertinib in the phase II SAVANNAH study.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This analysis from the phase II SAVANNAH study evaluated MET detection methods and cutoffs in EGFR-mutated NSCLC patients progressing on osimertinib. The study assessed MET overexpression by IHC and amplification by FISH to identify optimal cutoffs for savolitinib plus osimertinib treatment. Results showed confirmed ORR of 49% with MET IHC3+/≥90% and/or FISH10+ versus 9% without these markers, with prevalence estimated at 34% for the optimized cutoffs. The authors concluded that MET IHC3+/≥90% and/or FISH10+ are the most appropriate cutoffs, which will be used in the ongoing phase III SAFFRON study.
10.1158/1078-0432.CCR-26-0604
Final Biomarker and Efficacy Analyses of Lorlatinib in Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer in a Phase 2 Study.
J THORAC ONCOL · Q1 JOURNAL - RANK #3/108TOP-TIER
This study reports final biomarker and efficacy analyses from a global phase 2 trial of lorlatinib in patients with ALK-positive advanced non-small cell lung cancer. Plasma and tumor tissue samples were prospectively collected and analyzed via next-generation sequencing to correlate ALK fusion variants and co-mutations with clinical outcomes across three cohorts. EML4::ALK variant 3 and TP53 mutations were associated with shorter overall survival in the EXP2-3A cohort, while acquired ALK mutations emerged in pretreated but not treatment-naive patients. After 5 years of follow-up, lorlatinib demonstrated substantial activity and prolonged overall survival regardless of biomarker subgroups.
10.1016/j.jtho.2026.104202
Adjuvant Osimertinib in Resected EGFR-Mutated Stage IB-IIIA Non-Small Cell Lung Cancer: Exploratory 8-year Overall Survival Landmark Update from the ADAURA Trial [161/175].
J THORAC ONCOL · Q1 JOURNAL - RANK #3/108TOP-TIER
This exploratory 8-year overall survival (OS) landmark update from the ADAURA trial evaluated adjuvant osimertinib versus placebo in 682 patients with resected EGFR-mutated stage IB-IIIA non-small cell lung cancer. Patients were randomized to osimertinib or placebo until recurrence, treatment completion, or discontinuation, with updated survival data collected from 431 of 558 patients alive at the planned final OS analysis through yearly follow-up until May 2026. In the stage II-IIIA population, the OS hazard ratio (HR) was 0.53 (95% CI 0.38-0.75) with 8-year OS rates of 74% versus 58%, and in the stage IB-IIIA population, the OS HR was 0.52 (95% CI 0.39-0.71) with 8-year OS rates of 79% versus 64%. The authors conclude that these long-term results further characterize the established survival benefit of adjuvant osimertinib in this population.
10.1016/j.jtho.2026.104179
Sep 07 – Sep 14, 2026
Safety and Biomarker Analysis of NRG-LU004: Phase I Trial of Accelerated or Conventionally Fractionated Radiotherapy Combined With Durvalumab in PD-L1 High Locally Advanced Non-Small Cell Lung Cancer.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This phase I trial evaluated the safety and feasibility of concurrent durvalumab and radiotherapy without chemotherapy in stage II-III locally advanced NSCLC patients with PD-L1 >50%. Twenty-four patients received durvalumab (1500 mg Q4W x 13) with either accelerated (60 Gy/15 fractions) or standard (60 Gy/30 fractions) radiotherapy, with safety as the primary endpoint and biomarker analysis as exploratory. One dose-limiting toxicity occurred in the standard arm; adverse events included grade 3-5 toxicities in both arms, with durvalumab feasibility of 85% (accelerated) and 75% (standard), and RT completion per protocol in 12/12 and 10/12 patients, respectively. The authors concluded that chemotherapy-free thoracic radiotherapy with durvalumab is safe, with soluble proteomic analysis revealing immune changes and potential biomarkers of immune-related adverse events.
10.1016/j.ijrobp.2026.08.075
Long-term safety of first-line osimertinib plus platinum-pemetrexed in EGFR-mutated advanced NSCLC: FLAURA2.
LUNG CANCER · Q1 JOURNAL - RANK #19/108
This post-hoc analysis of the phase 3 FLAURA2 trial evaluated the long-term safety of first-line osimertinib plus platinum-pemetrexed in EGFR-mutated advanced NSCLC. Patients were randomized to combination therapy (four cycles of platinum-pemetrexed plus osimertinib, followed by osimertinib plus pemetrexed maintenance) or osimertinib monotherapy, and safety was characterized across induction (n=276), pemetrexed-maintenance (n=201), and osimertinib-only (n=206) periods. Onset frequency of any-grade/grade ≥3 treatment-related AEs was highest during induction (93%/43%), declining during maintenance (90%/25%) and osimertinib-only (58%/14%), with low discontinuation rates (≤8%). The authors conclude that the FLAURA2 regimen has a favorable long-term benefit-risk profile with declining grade ≥3 AE onset frequency over time and AE profiles consistent with individual agents.
10.1016/j.lungcan.2026.109588
Bevacizumab plus nab-paclitaxel and platinum as second-line therapy for driver-gene-negative non-squamous non-small cell lung cancer after immunochemotherapy: A prospective single-arm single-centre study.
CLIN TRANSL MED · Q1 JOURNAL - RANK #47/326
This prospective, single-arm, single-centre study evaluated the efficacy and safety of bevacizumab plus nab-paclitaxel and platinum (BAP regimen) as second-line therapy in 56 patients with advanced driver-gene-negative non-squamous non-small cell lung cancer who failed first-line immunochemotherapy. Patients received 4-6 cycles of the BAP regimen followed by bevacizumab maintenance, with objective response rate (ORR) as the primary endpoint and progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety as secondary endpoints. The confirmed ORR was 46.4% (26/56, 95% CI: 34.0%-59.3%, p<0.001), DCR was 75%, and median PFS and OS were 5.6 and 18.8 months, respectively. The BAP regimen demonstrated preliminary efficacy with manageable safety, and plasma TWEAK levels were identified as a potential biomarker for treatment response, warranting further validation.
10.1002/ctm2.70814
Ceralasertib plus durvalumab in Ras mutant and Ras wild type advanced non-small cell lung cancer: Two cohorts of the phase II platform National Lung Matrix Trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase II platform trial evaluated ceralasertib plus durvalumab in two parallel cohorts of immune checkpoint blockade-resistant advanced NSCLC, stratified by KRAS mutation status (mutant cohort J1, wild-type cohort NAJ). Forty-three patients were registered, with 19 and 18 evaluable in J1 and NAJ respectively; oral ceralasertib (240 mg twice daily days 15-28) was combined with durvalumab (1500 mg IV every 28 days). Bayesian-estimated 24-week durable clinical benefit rates were 37.7% for J1 and 29.3% for NAJ, with only two objective responses, both in KRAS mutant patients. The authors conclude that outcomes are modestly higher in KRAS mutant participants but not significantly different, likely reflecting the modest impact of KRAS mutation alone on LUAD immunobiology.
10.1158/1078-0432.CCR-26-1365
Osimertinib After Definitive Chemoradiotherapy in Unresectable Stage III EGFR-Mutated NSCLC: Subsequent Treatments and PPO From the Phase III LAURA Study.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This pre-specified analysis of the Phase III LAURA trial evaluated post-progression outcomes, subsequent treatments, and second interim overall survival (OS) in patients with unresectable stage III EGFR-mutated NSCLC. Patients were randomized 2:1 to receive osimertinib or placebo after definitive chemoradiotherapy, with open-label osimertinib offered post-progression. Osimertinib significantly improved time to first subsequent treatment (HR 0.13, 95% CI 0.08-0.21), second progression-free survival (HR 0.62, 95% CI 0.35-1.08), and time to second subsequent treatment (HR 0.51, 95% CI 0.28-0.91); second interim OS showed a trend favoring osimertinib (HR 0.67, 95% CI 0.40-1.14, 31% maturity). The authors conclude that clinical benefit with osimertinib is preserved beyond first progression, supporting long-term benefits in this setting.
10.1158/1078-0432.CCR-25-4523
Clinical utility of molecular residual disease detection in early-stage resected EGFR-mutated non-small cell lung cancer.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This prospective analysis of the phase 3 EVIDENCE trial evaluated molecular residual disease (MRD) in 175 patients with resected stage II-IIIA EGFR-mutated NSCLC receiving adjuvant icotinib or chemotherapy. Using the personalized tumor-informed MinerVa Prime assay on 1,352 plasma samples, MRD positivity was detected in 35.8% (38/106) of stage III and 14.7% (10/68) of stage II patients at the landmark timepoint, with a 47.4% longitudinal positivity rate. MRD positivity correlated with inferior disease-free survival (landmark HR: 4.44, P<0.001; longitudinal HR: 7.82, P<0.001), and icotinib improved DFS in both MRD subgroups. MRD demonstrated a 91.3% negative predictive value with a median lead time of 169 days before clinical recurrence. This prospective interventional trial analysis confirms MRD as a prognostic biomarker, showing icotinib enhances MRD clearance and reduces molecular recurrence compared to chemotherapy.
10.1038/s41467-026-76392-9
Induction and consolidation atezolizumab with stereotactic body radiation therapy versus radiation alone in high-risk, early-stage non-small-cell lung cancer (SWOG/NRG S1914): a multicentre, open-label, superiority, phase 3, randomised controlled trial.
LANCET · Q1 JOURNAL - RANK #1/332TOP-TIER
This multicentre, open-label, phase 3 randomised controlled trial (SWOG/NRG S1914) evaluated the addition of neoadjuvant, concurrent, and adjuvant atezolizumab to stereotactic body radiation therapy (SBRT) versus SBRT alone in 402 eligible patients with high-risk, early-stage (T1-T3N0M0) non-small-cell lung cancer who were medically inoperable or declined surgery. The trial was closed for futility at the first interim analysis, and an updated analysis at a median follow-up of 24.8 months showed no overall survival benefit (hazard ratio 1.04, 95% CI 0.69-1.58; one-sided p=0.58) with 2-year overall survival of 82% in both groups. Grade 3 or higher adverse events were more common with atezolizumab plus SBRT (12%) than with SBRT alone (3%), including two grade 5 respiratory events. The authors concluded that adding atezolizumab did not improve overall survival and increased toxicity in this patient population.
10.1016/S0140-6736(26)01655-7
Aug 31 – Sep 07, 2026
First-line pyrotinib plus apatinib in advanced non-small cell lung cancer harboring HER2 mutations or amplification: a phase II trial.
LUNG CANCER · Q1 JOURNAL - RANK #19/108
This single-arm, phase II clinical trial evaluated first-line pyrotinib plus apatinib in 22 treatment-naïve patients with stage IIIB-IV HER2-mutated or amplified non-small cell lung cancer. The primary endpoint was overall response rate (ORR), with secondary endpoints including disease control rate (DCR), progression-free survival (PFS), and safety. The ORR was 72.7% (95% CI, 49.8-89.3), the DCR was 95.5% (95% CI, 77.2-99.9), and median PFS was 10.7 months (95% CI, 6.6-14.8) after a median follow-up of 37.0 months. Grade 3-4 adverse events occurred in 27.3% of patients, with diarrhea being most common (18.2%), leading the authors to conclude that this combination is a promising, accessible, chemotherapy-sparing first-line therapy.
10.1016/j.lungcan.2026.109589
Pan-RAS Inhibitor Shows Activity in Advanced Lung Cancer.
CANCER DISCOV · Q1 JOURNAL - RANK #10/326TOP-TIER
This abstract reports on daraxonrasib, a first-in-class pan-RAS inhibitor, showing tumor shrinkage in more than 30% of patients with previously treated RAS-mutant non-small cell lung cancer. The study appears to be a prospective human clinical trial, given that it reports on patient responses to an active cancer treatment. Key findings include a response rate exceeding 30% in this patient population, building on prior results that led to approval for pancreatic cancer. The conclusions support an ongoing phase III trial, suggesting the study is an early-phase interventional trial, not a retrospective, systematic review, animal, in-vitro, protocol, or surgical-procedure study.
10.1158/2159-8290.CD-NW2026-0085
Clinical outcomes by type of surgery with perioperative durvalumab in patients with resectable non-small cell lung cancer.
J THORAC CARDIOV SUR · Q1 JOURNAL - RANK #20/312
This secondary analysis of the AEGEAN phase 3 double-blind, placebo-controlled randomized trial assessed outcomes with perioperative durvalumab by surgery type in 597 patients with resectable non-small cell lung cancer. Patients received neoadjuvant chemotherapy plus durvalumab or placebo before surgery, followed by adjuvant durvalumab or placebo. Key findings show pCR rates favored durvalumab across all surgery types: lobectomy (21.0% vs 5.4%), sleeve/bilobectomy (36.4% vs 5.4%), and pneumonectomy (7.4% vs 3.4%). EFS benefit also favored durvalumab (HR 0.64 [0.46-0.88] lobectomy; HR 0.59 [0.22-1.40] sleeve; HR 0.80 [0.36-1.74] pneumonectomy), with generally low surgical complication rates. The authors conclude that clinical benefit with perioperative durvalumab was maintained across surgery subgroups.
10.1016/j.jtcvs.2026.04.058
A phase II multi-institutional single arm trial evaluating TG4010 vaccine plus nivolumab in non-small cell lung cancer.
ONCOIMMUNOLOGY · Q1 JOURNAL - RANK #51/326
This phase II multi-institutional single-arm trial evaluated the safety and activity of the TG4010 MUC1 vaccine combined with nivolumab in ICI-naïve non-small cell lung cancer patients. The study targeted 29 evaluable patients but terminated early due to slow accrual after enrolling 13 patients. Treatment was well tolerated, with fatigue and injection site reactions being the most common adverse effects. Among 12 evaluable patients, only 1 (8.3%) achieved a response, 2 had disease control, and 9 progressed, with a median overall survival of 7.23 months. The study concluded that TG4010 plus nivolumab has limited clinical benefit, though one exceptional responder with a HER2 driver mutation achieved a durable complete response.
10.1080/2162402X.2026.2695491
Aug 24 – Aug 31, 2026
Three-year adjuvant treatment of icotinib in stage II-IIIA EGFR-mutated lung adenocarcinoma (ICWIP): a randomized, double-blind, placebo-controlled phase 3 trial.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This multicenter, double-blind, placebo-controlled, randomized phase 3 trial (ICWIP) evaluated 3-year adjuvant icotinib versus placebo in patients with completely resected stage II-IIIA EGFR-mutated lung adenocarcinoma who had completed four cycles of adjuvant chemotherapy. A total of 135 patients (66 icotinib, 69 placebo) were randomized. At a median follow-up of 78.3 months for icotinib and 69.9 months for placebo, IRC-assessed median disease-free survival (DFS) was significantly improved with icotinib (48.2 months vs 20.0 months; HR 0.54, 95% CI 0.34-0.87; p=0.011). The 3-year and 5-year DFS rates were 58.5% vs 36.1% and 39.4% vs 25.8% for icotinib versus placebo, respectively, while median overall survival was not reached (HR 0.84, p=0.65). Treatment-related adverse events occurred in 48.5% (icotinib) vs 23.2% (placebo) of patients, with a manageable safety profile. The authors conclude that 3-year adjuvant icotinib significantly improves DFS compared to placebo.
10.1038/s41392-026-02994-w
Perioperative Durvalumab for Resectable Non-Small Cell Lung Cancer: Updated Outcomes From the Phase III AEGEAN Trial.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This phase III, double-blind, placebo-controlled trial (AEGEAN) evaluated perioperative durvalumab plus neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in 740 patients with resectable non-small cell lung cancer (stage II-IIIB N2). Patients were randomized 1:1 to receive four cycles of neoadjuvant platinum-based chemotherapy plus durvalumab/placebo, followed by surgery and 12 cycles of adjuvant durvalumab/placebo. At a median follow-up of 25.9 months, event-free survival favored the durvalumab arm (HR 0.69, 95% CI 0.55-0.88), with numerical improvements in disease-free survival (HR 0.66, 95% CI 0.47-0.92) and overall survival (HR 0.89, 95% CI 0.70-1.14). Grade 3/4 adverse events during adjuvant treatment occurred in 15.4% of durvalumab versus 10.6% of placebo patients, supporting perioperative durvalumab plus chemotherapy as a viable treatment option.
10.1200/JCO-25-02659
AdvanTIG-301: a phase III study of ociperlimab plus tislelizumab and concurrent chemoradiotherapy in stage III unresectable non-small cell lung cancer.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This phase III multicenter, randomized, multiarm, open-label trial evaluated ociperlimab plus tislelizumab with concurrent chemoradiotherapy (cCRT) in treatment-naïve patients with unresectable stage III non-small cell lung cancer (NSCLC). Sixty-three patients were randomized to arm A (ociperlimab+tislelizumab+cCRT), arm B (tislelizumab+cCRT), or arm C (cCRT+durvalumab), but the trial was terminated early. Median progression-free survival was not reached in arm A, 15.0 months in arm B, and 10.4 months in arm C; objective response rates were 68.2%, 68.4%, and 59.1%, respectively, with all responses being partial. The authors concluded there was a trend toward improved efficacy with tislelizumab-based regimens, but data were descriptive only, and no unexpected safety signals were identified.
10.1136/jitc-2025-013527
Daily low-dose carboplatin or weekly carboplatin plus nab-paclitaxel for concurrent chemoradiotherapy in older patients with locally advanced non-small cell lung cancer (JCOG1914): A randomized phase 3 trial.
LUNG CANCER · Q1 JOURNAL - RANK #19/108
This open-label randomized phase 3 trial (JCOG1914) at 38 Japanese institutions enrolled 124 patients aged ≥75 years with locally advanced non-small cell lung cancer, randomly assigning them to daily low-dose carboplatin (30 mg/m²) or weekly carboplatin (AUC 2) plus nab-paclitaxel (30 mg/m²), both with concurrent thoracic radiotherapy. The primary endpoint was overall survival to assess non-inferiority of the weekly combination. The trial was terminated early for futility after a planned interim analysis showed a Bayesian predictive probability of non-inferiority of only 8.0%, with median overall survival not estimable in the carboplatin arm versus 26.1 months in the combination arm (HR 1.56; 95% CI 0.79-3.11; p=0.200). The carboplatin arm showed better quality of life at 6 weeks (OR 0.39; 95% CI 0.18-0.81; p=0.012), leading to the conclusion that daily low-dose carboplatin with radiotherapy remains the standard of care.
10.1016/j.lungcan.2026.109583
Adjuvant alectinib versus chemotherapy in resected ALK-positive non-small-cell lung cancer (ALINA): health-related quality-of-life and safety outcomes from a randomised, open-label, phase 3 trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This phase 3, open-label, randomized ALINA trial aimed to report safety and health-related quality-of-life (HRQoL) outcomes of adjuvant alectinib versus platinum-based chemotherapy in 257 patients with resected ALK-positive non-small-cell lung cancer. Patients were randomly assigned (1:1) to oral alectinib (600 mg twice daily for 24 months) or intravenous platinum-based chemotherapy (four 3-week cycles). Alectinib demonstrated a manageable safety profile with fewer discontinuations due to adverse events (7 [5%] vs. 15 [13%]) and clinically meaningful improvements in HRQoL domains (bodily pain, role physical, mental health, social functioning, vitality) at week 12, maintained over 2 years (week 96 mean Mental Component Summary: 49.9 [SD 10.4]; mean Physical Component Summary: 48.8 [SD 7.2]). The study concluded that adjuvant alectinib’s manageable safety and improved HRQoL, alongside its previously reported disease-free survival benefit, support its adoption as a new standard-of-care.
10.1016/S1470-2045(26)00283-4
Ivonescimab plus chemotherapy versus placebo plus chemotherapy in patients with advanced EGFR-mutated non-small-cell lung cancer after disease progression on EGFR tyrosine kinase inhibitor therapy (HARMONi): a multicentre, randomised, double-blind, phase 3 trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This multicentre, randomised, double-blind, phase 3 trial (HARMONi) evaluated ivonescimab plus chemotherapy versus placebo plus chemotherapy in 438 patients with advanced EGFR-mutated NSCLC after progression on EGFR-TKI therapy. The primary endpoints were progression-free survival and overall survival in the intention-to-treat population. At a median follow-up of 22.3 months, median progression-free survival was significantly improved with ivonescimab versus placebo (6.8 vs 4.4 months; HR 0.52, 95% CI 0.41-0.66; p<0.0001). Overall survival was not statistically significant (16.8 vs 14.0 months; HR 0.79, 95% CI 0.62-1.01). The authors concluded that ivonescimab plus chemotherapy provides a clinically meaningful progression-free survival benefit with no new safety signals, supporting its potential as a new treatment option.
10.1016/S1470-2045(26)00282-2
Sutetinib for Patients with Non-Small Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Multicenter, Open-Label, Phase IIb Trial.
J THORAC ONCOL · Q1 JOURNAL - RANK #3/108TOP-TIER
This multicenter, open-label, single-arm phase IIb trial evaluated sutetinib, an irreversible EGFR-TKI, in 99 adults with locally advanced or metastatic NSCLC harboring uncommon EGFR mutations (G719X, S768I, L861Q, or predefined compound mutations) who had no prior EGFR-TKI therapy. Patients received sutetinib 80 mg orally once daily in 28-day cycles until progression or unacceptable toxicity. The primary endpoint, IRC-confirmed objective response rate, was 70.8% (95% CI, 60.7-79.7) in 96 efficacy-evaluable patients, with a disease control rate of 90.6%, median duration of response of 12.0 months, and median progression-free survival of 13.7 months; median overall survival was not reached. Grade ≥3 treatment-related adverse events occurred in 42.4% of patients, with no treatment-related deaths, supporting sutetinib as a potential treatment option for this population.
10.1016/j.jtho.2026.104165
Aug 17 – Aug 24, 2026
Five-Year Outcomes of Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer From the Randomized KEYNOTE-671 Study.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
This phase 3, randomized, double-blind, placebo-controlled trial (KEYNOTE-671) evaluated perioperative pembrolizumab plus neoadjuvant chemotherapy versus chemotherapy plus surgery alone in 797 patients with resectable early-stage (II, IIIA, IIIB-N2) NSCLC. After a median follow-up of 60.4 months, the 5-year event-free survival was 49.9% with pembrolizumab versus 26.5% with placebo (HR 0.58, 95% CI 0.48-0.69), and 5-year overall survival was 64.6% versus 53.6%, respectively (HR 0.74, 95% CI 0.59-0.92). Quality of life was not detrimentally affected, and safety profiles were consistent with known toxicities. The authors concluded that perioperative pembrolizumab provides durable, clinically meaningful survival benefits and represents a standard of care for this patient population.
10.1016/j.annonc.2026.08.005
T cell receptor repertoire dynamics and newly identified functional regulators of autologous tumor-infiltrating lymphocyte therapy in advanced solid tumors.
J TRANSL MED · Q1 JOURNAL - RANK #24/195
This phase I investigator-initiated trial evaluated the safety, feasibility, and preliminary efficacy of autologous tumor-infiltrating lymphocyte (TIL) therapy in twelve Asian patients with advanced melanoma, cervical, lung, or head and neck cancers who had progressed after standard therapies. Patients received lymphodepletion chemotherapy, TIL infusion, and high-dose IL-2, with tumor assessments per RECIST 1.1. The objective response rate was 33.3% (4/12), including one complete response and three partial responses, with a disease control rate of 75% (9/12). TCR sequencing showed dynamic clonal remodeling in responders, and CRISPR-mediated knockout of ASS1 or CEP20 enhanced TIL antitumor function, suggesting these genes as potential targets to improve TIL therapy.
10.1186/s12967-026-08781-z
A Phase I Study of Cyclical Hypofractionated Palliative Radiotherapy (Quad Shot) for Central Lung Tumors in Patients with Stage IV Non-Small Cell Lung Cancer (NSCLC): Results from the PROMISE 006 Trial Thoracic Quad Shot RT in Stage IV NSCLC.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This prospective phase I dose-escalation trial evaluated the safety, feasibility, and patient-reported outcomes of cyclical hypofractionated palliative radiotherapy (Quad Shot) administered concurrently with systemic therapy in 45 patients with stage IV non-small cell lung cancer. The primary endpoint was to determine the maximum tolerated number of treatment cycles using a modified 3+3 design, with dose-limiting toxicity defined as a rate ≤17%. Results showed one dose-limiting toxicity in the two-cycle cohort, none in the three-cycle cohort, establishing three cycles as the maximum tolerated dose, with only three grade 3 radiotherapy-related toxicities in the expansion cohort. All systemic therapies were administered without interruptions, and symptomatic patients reported improvement in dyspnea (67%), cough (62%), and hemoptysis (100%), supporting the regimen’s use as a palliative option.
10.1016/j.ijrobp.2026.08.023