✦ Cancer Clinical Trials

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Small Cell Lung Cancer

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Jul 06 – Jul 13, 2026

Consolidative Thoracic Radiotherapy With Atezolizumab Maintenance in Extensive-Stage Small Cell Lung Cancer: The Phase 2 TREASURE Randomized Clinical Trial (AIO-TRK-0320).
JAMA ONCOL · Q1 JOURNAL - RANK #14/326TOP-TIER
This multicenter, open-label, phase 2 randomized trial (NCT04462276) evaluated whether adding consolidative thoracic radiotherapy (30 Gy/10 fractions) to atezolizumab maintenance after carboplatin–etoposide–atezolizumab induction improves outcomes in extensive-stage small-cell lung cancer. Sixty-eight patients with at least stable disease after induction chemoimmunotherapy were randomized 1:1 to atezolizumab plus radiotherapy (arm A) or atezolizumab alone (arm B) and followed until September 2024, with a survival update in April 2026. Median overall survival was 6.7 months (95 % CI 5.1-9.0) in arm A versus 13.4 months (95 % CI 10.7-17.5) in arm B (HR 1.55, P = 0.34); median progression-free survival was 2.4 versus 2.6 months (HR 0.92, P = 0.85). Radiotherapy markedly increased severe adverse events (61.3 % vs 18.2 %, P < 0.001) and fatalities (19.4 % vs 3.0 %, P = 0.04); investigators concluded that unselected use of consolidative thoracic radiotherapy with maintenance atezolizumab confers excess toxicity without survival benefit.
10.1001/jamaoncol.2026.2330

Jun 29 – Jul 06, 2026

Peripheral immune cell subsets as potential predictors of benefit from immune checkpoint blockade therapy in small cell lung cancer.
FRONT IMMUNOL · Q1 JOURNAL - RANK #32/183
This prospective clinical trial investigated peripheral immune cell dynamics as predictors of immune checkpoint blockade therapy (ICBt) benefit in small cell lung cancer (SCLC). Patients from eight centers were recruited into three cohorts: chemotherapy alone (Ct, N=24), Ct+anti-CTLA-4 (N=37), and Ct+anti-PD-1/PD-L1 (N=20). PBMCs were collected before and 3-4 weeks after treatment, with immune markers assessed via FACS; survival analysis used Kaplan-Meier and MaxStat. Six immune subsets predicted survival, including increased CD8+CD103+Ki67+ cells (p=0.043, 0.0033) and Ki67 upregulation in CD4+ T cells (p=0.012, 0.0027), suggesting early on-treatment changes may improve predictive value.
10.3389/fimmu.2026.1802274

Jun 22 – Jun 29, 2026

Durvalumab plus etoposide-platinum in patients with epidermal growth factor receptor (EGFR)-mutated advanced NSCLC and neuroendocrine transformation after first-line osimertinib: ORCHARD.
LUNG CANCER · Q1 JOURNAL - RANK #19/108
This open-label, phase 2 module of the ORCHARD platform trial evaluated durvalumab 1,500 mg IV every 3 weeks plus etoposide-platinum every 3 weeks (up to four cycles; durvalumab continued until progression/toxicity) in EGFR-mutated advanced NSCLC with neuroendocrine transformation after progression on first-line osimertinib. The primary endpoint was investigator-assessed ORR per RECIST 1.1, with secondary endpoints of PFS, DoR, OS, and safety; 14 patients were treated and evaluable. Confirmed ORR was 43% (80% CI 24–63) with six partial responses; median DoR was 4.3 months (95% CI 3.0–not calculable), median PFS 4.2 months (95% CI 3.0–5.6), and median OS 10.2 months (95% CI 4.3–16.8). Grade ≥3 AEs occurred in 64% (most commonly neutropenia/decreased neutrophils), and the regimen produced modest activity without new safety signals.
10.1016/j.lungcan.2026.109501

First-line serplulimab plus chemotherapy versus chemotherapy alone in small-cell lung cancer patients with brain metastases: a multicenter, prospective cohort study.
FRONT IMMUNOL · Q1 JOURNAL - RANK #32/183
This multicenter, prospective cohort study evaluated the efficacy and safety of first-line serplulimab plus chemotherapy versus chemotherapy alone in 62 small-cell lung cancer (SCLC) patients with brain metastases (BM). The primary endpoint was intracranial progression-free survival (iPFS), with secondary endpoints including extracranial PFS, systemic PFS, overall survival (OS), tumor response, and safety. The serplulimab group showed significantly improved median iPFS (8.93 vs. 6.37 months; log-rank p=0.004) and OS (28.77 vs. 12.95 months; log-rank p<0.001), with an intracranial objective response rate of 78.57%. The study concluded that serplulimab plus chemotherapy offers robust intracranial efficacy and survival benefits with manageable safety, and integrating cranial radiotherapy enhances clinical outcomes.
10.3389/fimmu.2026.1858418

Jun 01 – Jun 08, 2026

First-Line Serplulimab in Extensive-Stage Small Cell Lung Cancer: Secondary Analysis of the ASTRUM-005 Phase 3 Randomized Clinical Trial.
JAMA ONCOL · Q1 JOURNAL - RANK #14/326TOP-TIER
This international, double-blind, phase 3 randomized clinical trial (ASTRUM-005) secondary analysis evaluated long-term efficacy, safety, patient-reported outcomes, and exploratory biomarkers for serplulimab plus carboplatin/etoposide versus placebo plus chemotherapy in previously untreated extensive-stage small cell lung cancer. A total of 585 patients were randomized 2:1 to serplulimab 4.5 mg/kg or placebo with up to 4 cycles of carboplatin/etoposide; median follow-up was 42.4 months and the primary endpoint was overall survival. Serplulimab improved median overall survival to 15.8 months (95% CI, 13.9-17.4) versus 11.1 months (95% CI, 10.0-12.4), hazard ratio 0.60 (95% CI, 0.49-0.73; P<.001), with 4-year OS rates of 21.9% versus 7.2%; grade ≥3 treatment-emergent adverse events occurred in 35.0% versus 29.1%. Patient-reported outcomes favored serplulimab for overall health, dyspnea, pain, and faster alopecia recovery, supporting it as a first-line standard of care.
10.1001/jamaoncol.2026.1645

Sintilimab plus concurrent chemoradiotherapy for treatment of locally advanced small cell lung cancer (SINCE-01): a phase II clinical trial.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This single-arm phase II trial evaluated sintilimab combined with concurrent chemoradiotherapy (CCRT) in 22 patients with histologically confirmed limited-stage small cell lung cancer and good performance status. Patients received four 3-weekly chemotherapy cycles plus sintilimab with thoracic radiation (45 Gy in 30 fractions); the primary endpoint was progression-free survival (PFS). After 44.7 months median follow-up, median PFS was 29.6 months (12- and 24-month PFS 72.7% and 54.5%), median overall survival 40.6 months (12- and 24-month OS 95.5% and 72.7%), and objective response rate 95.5%; grade 3–4 toxicities were mainly hematologic, pneumonitis occurred in 3 patients (≥G2 in one), and no treatment-related deaths occurred. Higher tumor HLA-I expression correlated with longer PFS, supporting concurrent sintilimab-CCRT as effective with manageable safety.
10.1038/s41392-026-02668-7

SEZ6-targeting antibody-drug conjugate ABBV-706 in advanced small cell lung cancer and solid tumors: a phase 1 trial.
NAT MED · Q1 JOURNAL - RANK #1/195TOP-TIER
This open-label, phase 1 clinical trial assessed the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ABBV-706, a SEZ6-targeting antibody-drug conjugate, in 288 patients with advanced solid tumors, with a focus on 124 relapsed/refractory (R/R) small cell lung cancer (SCLC) patients. ABBV-706 was administered intravenously every 3 weeks, with safety outcomes highlighting anemia (61%) and fatigue (38%) as the most common treatment-related adverse events in the monotherapy cohort, and grade 3 or higher adverse events in 61% of R/R SCLC patients. Efficacy data showed an objective response rate of 52% in R/R SCLC, with comparable ORRs (56% and 59%) between 1.8 mg/kg and 2.5 mg/kg doses and median overall survival of 12.4 months at 1.8 mg/kg. The study concluded 1.8 mg/kg as the recommended phase 2 dose based on safety and efficacy.
10.1038/s41591-026-04452-0

May 25 – Jun 01, 2026

Durvalumab plus anlotinib versus durvalumab alone as maintenance treatment in extensive-stage small-cell lung cancer (DURABLE): a multicenter, randomized, phase II trial and biomarker analysis.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
The DURABLE trial was a prospective, multicenter, randomized phase II study (NCT04985851) comparing durvalumab plus anlotinib versus durvalumab alone as maintenance therapy in 66 patients with extensive-stage small-cell lung cancer (ES-SCLC) after first-line durvalumab plus platinum-etoposide chemotherapy. The primary endpoint, progression-free survival (PFS), showed a median of 5.4 months for the durvalumab plus anlotinib group versus 1.9 months for durvalumab alone (HR=0.64; 80% CI, 0.44-0.94; p=0.12), with grade 3-4 adverse events occurring in 24.2% and 12.5% of patients, respectively. Biomarker analysis indicated improved outcomes with combined therapy in patients with impaired antigen presenting capacity or low bTMB. The study concludes that durvalumab plus anlotinib is a potentially effective and well-tolerated maintenance option for ES-SCLC.
10.1038/s41467-026-73562-7