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SCLCJuly 2026
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Small Cell Lung Cancer — Monthly Compass
Jul 01–31, 2026 • Priority Updates • 3–5 minute read
 
A curated, practice-minded digest of what moved in small cell lung cancer this month — regulatory signals, clinical development, and the most practice-relevant publications.
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small cell lung cancer updates
Key Highlights
Key Highlights
  • Practice-Changing Updates
    • EU approval and initial implementation of lurbinectedin plus atezolizumab as first‑line maintenance for extensive‑stage SCLC signal a chemo‑IO‑plus maintenance approach, with early roll‑out in Germany and Austria.
    • July reporting from TREASURE (AIO‑TRK‑0320) showed that adding consolidative thoracic radiotherapy to PD‑L1 maintenance increased severe and fatal toxicity without survival benefit, supporting selective rather than routine TRT in first‑line ES‑SCLC.
  • Key Clinical Development Updates
    • FDA accepted and granted Priority Review to the BLA for ifinatamab deruxtecan (I‑DXd) in previously treated extensive‑stage SCLC, with a PDUFA target action date of October 10, 2026.
    • Genprex reported that Acclaim‑3 (quaratusugene ozeplasmid/REQORSA plus atezolizumab) for ES‑SCLC maintenance holds FDA Fast Track and Orphan Drug designations, with a Phase 2 expansion ongoing and an interim analysis planned after the first 25 patients.
  • Key Conference Updates
    • At the July Thoracic Malignancies Summit and the Interim Lung Update, faculty emphasized moving immunotherapy maintenance earlier across LS‑ and ES‑SCLC and highlighted growing momentum for DLL3‑directed strategies in the post‑platinum setting.
  • Emerging Themes & Macro-Trends
    • DLL3‑targeted modalities are expanding beyond T‑cell engagers to include ADCs advancing in the DLLEVATE phase 3 trial with ORR and OS co‑primary endpoints and alpha‑emitting radiotheranostics pairing DLL3 PET imaging with Pb‑212 therapy to deliver on‑target radiation.
    • Care models in SCLC are shifting toward IO‑anchored maintenance with selective local therapy, prompting prioritization of DLL3 testing pathways, theranostic infrastructure, and EU access strategies.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • On July 22, 2026, the FDA approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who had received at least one prior ROS1 tyrosine kinase inhibitor (TKI). This approval was based on efficacy data from the ARROS-1 trial, which evaluated overall response rate and duration of response in previously treated patients with ROS1-positive NSCLC.¹ (read more)
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Daiichi Sankyo reported Q1 FY2026 results and reiterated that the FDA has accepted and granted Priority Review to the BLA for ifinatamab deruxtecan (I‑DXd) in previously treated extensive-stage small cell lung cancer, with a PDUFA target action date of October 10, 2026. The company highlighted the ongoing U.S. review timeline in its July 31, 2026 financial update. ¹ (read more)
  • Genprex filed a July 14, 2026 Form 8‑K stating that Acclaim‑3 (quaratusugene ozeplasmid/REQORSA + atezolizumab) for extensive‑stage small cell lung cancer has FDA Fast Track designation and FDA Orphan Drug designation; the Phase 2 expansion is ongoing with an interim analysis planned after the first 25 patients. The update confirms continued FDA‑recognized expedited-development status for this SCLC maintenance program. ² (read more)
Conference
Major Conference Updates
Conference Information
  • 5th Summit on Thoracic Malignancies, Fairmont Orchid, Kona, Hawaii; July 7–11, 2026. (read more)
  • Interim Lung Update 2026 (virtual, Zoom); July 28, 2026. Overall sentiment: momentum is building around earlier immunotherapy maintenance and DLL3-directed strategies, while radiotherapy use in ES‑SCLC is being recalibrated for safety. (read more)
  • Theme 1: Immunotherapy Maintenance Moves Earlier
    • Significance: Education and regulatory actions in July emphasized consolidating first‑line gains with maintenance in both LS‑ and ES‑SCLC. (read more)
    • Mechanism insights / clinical impact: Post‑CCRT durvalumab (ADRIATIC) is described as practice‑changing in LS‑SCLC; in ES‑SCLC, lurbinectedin plus atezolizumab (IMforte) secured EU approval for first‑line maintenance, signaling a chemo‑IO‑plus approach to sustain response after induction. (read more)
    • Patient populations affected: LS‑SCLC after concurrent chemoradiation; ES‑SCLC with disease control post‑platinum/IO induction across EU markets (initial roll‑out in Germany/Austria) and education efforts targeting broad community uptake. (read more)
  • Theme 2: Radiotherapy Strategy Recalibration in ES‑SCLC
    • Significance: New July reporting from TREASURE (AIO‑TRK‑0320) challenges adding consolidative thoracic radiotherapy (TRT) to atezolizumab maintenance, reprioritizing benefit–risk. (read more)
    • Mechanism insights / clinical impact: When layered on PD‑L1 maintenance, TRT increased severe and fatal toxicity without improving survival—supporting selective, not routine, consolidation and reinforcing systemic maintenance as the therapeutic backbone. (read more)
    • Patient populations affected: First‑line ES‑SCLC patients entering IO maintenance; programs should refine TRT use to symptomatic/oligoprogressive settings rather than default practice. (read more)
  • Theme 3: DLL3-Directed Radiotheranostics Emerge
    • Significance: Alpha‑emitting radiopharmaceuticals targeting DLL3 advanced into clinics, offering image‑guided patient selection and tumor‑localized radiation. (read more)
    • Mechanism insights / clinical impact: A lead‑203/lead‑212 theranostic pair enables DLL3 PET imaging to confirm target engagement, then delivers targeted alpha therapy (Pb‑212) to DLL3‑expressing SCLC—aiming to maximize on‑target kill and spare normal tissue. (read more)
    • Patient populations affected: Recurrent/progressive SCLC with DLL3 expression at limited U.S. centers; access contingent on nuclear medicine capacity and tracer uptake on diagnostic imaging. (read more)
  • Theme 4: ADC Momentum Around DLL3 (Post‑Platinum Landscape)
    • Significance: July updates highlighted regulatory tailwinds and registrational movement for DLL3‑targeted ADCs, signaling diversification beyond T‑cell engagers. (read more)
    • Mechanism insights / clinical impact: Zocilurtatug pelitecan (DLL3 ADC) received orphan designation in NECs; the DLLEVATE phase 3 trial compares monotherapy vs investigator’s choice with ORR and OS co–primary endpoints—positioning ADCs for cytotoxic delivery while potentially reducing off‑tumor exposure. (read more)
    • Patient populations affected: Relapsed ES‑SCLC after first‑line platinum, globally recruiting across U.S./EU/Asia; potential utility across neuroendocrine phenotypes with DLL3 expression. (read more)
  • Significance
    • Expected clinical or translational readouts: Early safety/uptake data from DLL3 radiotheranostics; DLLEVATE interim milestones; additional ADRIATIC practice‑integration updates. (read more)
    • Regulatory or policy implications: EU implementation of Zepzelca (lurbinectedin) + Tecentriq (atezolizumab) first‑line maintenance; Japan NDA submitted for the same indication. (read more)
    • Potential shifts in standard of care: Broader adoption of maintenance IO in LS‑ and ES‑SCLC; restraint on routine consolidative TRT with IO; future incorporation of DLL3‑targeted radiotherapeutics/ADCs as post‑platinum standards pending outcomes. (read more)
    • Strategic implications: Prioritize DLL3 testing pathways, theranostic infrastructure, and EU access strategies; design IO‑anchored care models with selective local therapy; prepare for ADC/TCE competition in the relapsed setting. (read more)
Publications Related to Approved Drugs
Phase 3
atezolizumab, atezolizumab and hyaluronidase-tqjs, durvalumab
Validation of the lung immune prognostic index in extensive-stage small cell lung cancer: Post hoc analysis of the caspian and IMpower133 phase 3 trials. This large post-hoc analysis of the CASPIAN and IMpower133 trials validates the Lung Immune Prognostic Index (LIPI) as a robust and clinically applicable prognostic biomarker in extensive-stage small-cell lung cancer (ES-SCLC). Patients categorized with a poor LIPI score demonstrated substantially worse survival outcomes and derived limited benefit from immunotherapy, underscoring the urgent need for novel therapeutic strategies for this high-risk subgroup. (, )
New Publications Related to Drugs in Clinical Trial Development
Phase 3
PROSPECT-LUNG: A National Clinical Trials Network Trial Advancing Pragmatic Innovation in Cancer Clinical Trials. The PROSPECT-Lung trial () introduces a pragmatic phase III design for resectable NSCLC that significantly reduces trial complexity, data collection fields (by 82.6%), and site workload compared to traditional designs. This streamlined approach serves as a replicable model to enhance the efficiency and real-world relevance of future cancer clinical trials while maintaining scientific rigor. ()
Phase 2
High-dose furmonertinib as first-line treatment for untreated EGFR-mutated advanced NSCLC with central nervous system metastases: A phase 2 trial. In a phase II study, high-dose furmonertinib (160 mg daily) demonstrated promising intracranial efficacy as a first-line treatment for patients with EGFR-mutated NSCLC and CNS metastases. The therapy achieved a median intracranial progression-free survival of 17.83 months and an intracranial objective response rate of 95.0%, with a manageable safety profile. ()
Phase 2
First-Line Sacituzumab Govitecan Plus Pembrolizumab and Carboplatin in Metastatic Non-Small Cell Lung Cancer: Nonsquamous and Squamous Cohorts of the EVOKE-02 Study. The EVOKE-02 phase II trial showed that first-line sacituzumab govitecan (at a reduced 7.5 mg/kg dose) combined with pembrolizumab and carboplatin has promising clinical activity in metastatic NSCLC. The regimen achieved objective response rates of 45.1% in nonsquamous and 39.0% in squamous histologies, with median progression-free survival over 8 months in both cohorts. ()
Phase 1
Datopotamab Deruxtecan Plus Pembrolizumab With or Without Platinum-Based Chemotherapy for Advanced or Metastatic NSCLC: The Phase Ib TROPION-Lung02 Trial. The phase Ib TROPION-Lung02 study found that datopotamab deruxtecan (Dato-DXd) plus pembrolizumab, with or without platinum chemotherapy, exhibited a manageable safety profile and durable antitumor activity in treatment-naive patients with advanced NSCLC. The doublet therapy achieved a 54.8% objective response rate and a median progression-free survival of 11.2 months, with responses observed across all PD-L1 expression levels. ()
PHASE1, PHASE2
PARP inhibition combined with a T-cell receptor β chain-directed antibody fusion molecule drives polyclonal antitumor immunity and tumor regression. Preclinical findings suggest that combining a PARP inhibitor (olaparib) with a selective T-cell agonist (mSTAR1302) induces significant tumor regression and enhances antitumor immunity in immune-excluded prostate cancer models. This provides a strong mechanistic rationale for the clinical evaluation of this combination strategy to overcome immune exclusion in solid tumors like mCRPC. ()
Phase 1
BCL-2/BCL-xL inhibitor pelcitoclax with osimertinib for <i>EGFR</i>-mutated advanced non-small-cell lung cancer: a phase 1b trial. In a phase 1b trial, the combination of pelcitoclax and osimertinib demonstrated a promising safety profile and significant antitumor activity in TKI treatment-naïve patients with EGFR-mutated NSCLC, achieving an 80.8% objective response rate and a 16.4-month median progression-free survival. However, efficacy was limited in patients who had previously progressed on third-generation TKI treatment plus chemotherapy. ()
Phase 3
Izalontamab Brengitecan (Iza-Bren), a First-in-Class EGFR-HER3 Bispecific Antibody-Drug Conjugate in Extensive-Stage Small Cell Lung Cancer: Results From a Phase Ib Study. The first-in-class bispecific ADC, Izalontamab brengitecan (iza-bren), demonstrated encouraging antitumor activity in relapsed extensive-stage SCLC, with an overall objective response rate of 48.1%. In the second-line setting, the ORR was particularly high at 72.7% with a median overall survival of 15.0 months, supporting its ongoing evaluation in a phase III trial. ()
Phase 1
The role of zongertinib, a highly selective tyrosine kinase inhibitor, in targeting <i>HER2</i>-mutant NSCLC: a bench-to-bedside review. Zongertinib, a recently approved oral, irreversible HER2-selective TKI, has shown encouraging and durable activity with a manageable safety profile in patients with previously treated advanced HER2-mutant NSCLC. This agent provides a convenient and effective treatment option that minimizes EGFR-related toxicities, with ongoing trials assessing its potential in the first-line setting and in novel combinations. ()
Phase 2
Osimertinib Plus Gefitinib in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer and EGFR (C797X) Mutation Following First-Line Osimertinib: ORCHARD. The ORCHARD phase II study concluded that combining osimertinib with gefitinib provides only modest clinical benefit for patients with EGFR-mutated NSCLC who develop the C797X resistance mutation after first-line osimertinib. With a confirmed objective response rate of 26% and a median progression-free survival of 5.1 months, the risk-benefit profile does not warrant further evaluation of this regimen. ()
Phase 3
Aumolertinib with or without chemotherapy in EGFR-mutated advanced non-small-cell lung cancer (AENEAS2): an open-label, multicentre, randomised, controlled, phase 3 trial. The phase 3 AENEAS2 trial demonstrated that first-line aumolertinib plus chemotherapy significantly improved progression-free survival to 28.9 months, compared to 18.9 months with aumolertinib monotherapy, in patients with advanced EGFR-mutated NSCLC. This establishes the combination as a potential new standard of care, despite an increase in manageable hematologic toxicities. ()
Phase 2
A phase II basket trial of DART SWOG S1609: the salivary gland tumor cohort. In the DART phase II trial, the combination of ipilimumab plus nivolumab demonstrated limited efficacy in patients with salivary gland tumors, yielding low objective response rates of 4% in adenoid cystic carcinoma and 9% in other histologies. Although some durable stable disease was noted, the results suggest a minimal role for dual checkpoint inhibition in this rare tumor population. ()
Phase 3
Bispecific Antibody Ivonescimab Added to Chemotherapy in EGFR-Variant Non-Small Cell Lung Cancer: The HARMONi-A Randomized Clinical Trial. The phase 3 HARMONi-A trial showed that adding the bispecific antibody ivonescimab (targeting PD-1 and VEGF) to chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival for patients with EGFR-variant NSCLC who had progressed on prior TKI therapy. The combination extended median overall survival to 16.8 months versus 14.1 months for chemotherapy alone, with an acceptable safety profile. ()
Phase 2
Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein Overexpressing, Nonsquamous, <i>EGFR</i> Wild-type Advanced NSCLC: Updated Analysis of the LUMINOSITY Trial. An updated analysis of the phase 2 LUMINOSITY trial confirms that the c-Met-directed ADC telisotuzumab vedotin (Teliso-V) elicits durable responses in patients with previously treated, c-Met overexpressing, EGFR wild-type nonsquamous NSCLC. The therapy achieved an overall response rate of 29.2% and a median duration of response of 7.2 months, irrespective of prior platinum or immune checkpoint inhibitor therapy. ()
Phase 2
Comparative efficacy of taletrectinib versus first-generation TKIs in TKI-naïve ROS1+ non-small cell lung cancer: A matching-adjusted indirect comparison. A matching-adjusted indirect comparison of clinical trial data suggests that the next-generation TKI taletrectinib is associated with significantly more favorable response and survival outcomes than first-generation TKIs (crizotinib and entrectinib) in TKI-naïve patients with ROS1+ NSCLC. This analysis supports taletrectinib as a highly effective first-line treatment option in this patient population. ()
Phase 3
Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer in China: a multicentre, single-arm expansion cohort from a phase 1b/2 trial. The dual-oral, chemotherapy-free regimen of ifebemtinib (FAK inhibitor) plus garsorasib (KRASG12C inhibitor) demonstrated encouraging efficacy as a first-line treatment for KRASG12C-mutated NSCLC, achieving a confirmed objective response rate of 82%. This combination showed a manageable safety profile, and a randomized phase 3 study has been initiated to validate these findings. ()
Phase 2
Divergent Tumor Immune Microenvironment and Response to Neoadjuvant Chemoimmunotherapy in Resectable Non-Small Cell Lung Cancer: A Single-Arm Phase II Trial. In a phase II trial, neoadjuvant pembrolizumab plus chemotherapy achieved a 37.5% major pathological response (MPR) rate in resectable NSCLC. Spatial transcriptomics of resected tumors identified distinct lymphoid-enriched and myeloid-enriched immune phenotypes associated with response, suggesting that these spatial biomarkers could help stratify patients for adjuvant immunotherapy. ()
Phase 1
Phase I Study of Telisotuzumab Adizutecan (Temab-A, ABBV-400), a Novel c-Met Antibody-Drug Conjugate, in Patients With Late-Line Colorectal Cancer and Advanced Solid Tumors. The novel c-Met targeting antibody-drug conjugate Temab-A (telisotuzumab adizutecan) demonstrated a tolerable safety profile and promising antitumor activity in a phase I study of heavily pretreated patients with metastatic colorectal cancer. At doses of 2.4 mg/kg and 3.0 mg/kg, the agent showed encouraging responses, supporting 2.4 mg/kg as the go-forward dose for further investigation. ()
Phase 1
Safety and efficacy of DLL3 CAR-T cells armored with dnTGFBR2 in a subject with recurrent small-cell lung cancer: case report. This case report highlights the real-world efficacy of the investigational DLL3-targeting CAR-T cell therapy, LB2102, in a patient with extensive-stage SCLC who was ineligible for the clinical trial. The patient experienced a positive and long-term response to the off-label treatment, demonstrating its potential as a novel therapeutic strategy for this aggressive disease. ()
N/A
CT-guided intratumoral immunotherapy for advanced solid tumors: a prospective clinical study of safety and systemic antitumor effects. A pooled analysis of prospective clinical trials involving 169 patients confirms that CT-guided intratumoral injection of immunotherapies is a safe delivery method with a low rate of severe (Grade 3-4) adverse events (8.88%). This approach shows preliminary therapeutic potential, achieving a disease control rate of 95.27%, and may be a promising strategy to mitigate the systemic toxicity associated with intravenous administration. ()
PHASE1, PHASE2
The dynamic evolution of circulating tumor cells during glecirasib treatment predicts survival and resistance in gastrointestinal tumors with KRASG12C mutation. This study demonstrates that longitudinal monitoring of circulating tumor cell (CTC) subtypes can predict outcomes in patients with KRASG12C-mutated gastrointestinal tumors treated with the inhibitor glecirasib. Lower baseline CTC counts were associated with longer survival, and dynamic changes in CTC subtypes correlated with clinical progression, highlighting CTCs as a valuable biomarker for response and resistance. ()
Phase 2
Safety and efficacy of fecal microbiota transplantation in solid cancers resistant to immune checkpoint inhibitors: results of the MITRIC trial. The phase IIa MITRIC trial found that while fecal microbiota transplantation (FMT) combined with ICIs was safe and feasible in patients with advanced, ICI-refractory cancers, it showed limited clinical activity. No objective responses were observed, although one melanoma patient achieved long-term stable disease, suggesting further research is needed to identify appropriate patient populations and donor criteria. ()
PHASE1, PHASE2
Multikinase Inhibition with Tinengotinib in Advanced Solid Tumors: Results from a Multicenter Phase Ib/II Trial. The multikinase inhibitor tinengotinib demonstrated a manageable safety profile and notable antitumor activity across several advanced solid tumors, including prostate cancer (33.3% ORR), breast cancer (30.0% ORR), and cholangiocarcinoma (13.0% ORR). The study supports a 10-mg daily dose and highlights the potential for biomarker-informed strategies, particularly involving FGFR2 fusions in cholangiocarcinoma. ()
Phase 2
Efficacy and safety of subcutaneous and intravenous administration of atezolizumab in patients with non-small cell lung cancer, including early-stage, locally advanced or metastatic disease: Updated results of the IMscin001 and IMscin002 randomized studies. Updated results from the IMscin001 and IMscin002 studies confirm that subcutaneous atezolizumab offers a similar efficacy and safety profile to the intravenous formulation for patients with NSCLC. With comparable overall survival and no new safety signals, the subcutaneous option provides a well-tolerated and more convenient administration route for patients. ()
Phase 3
Phase III Study of Niraparib Plus Pembrolizumab as Maintenance Therapy for Advanced or Metastatic NSCLC (ZEAL-1L). The phase 3 ZEAL-1L trial concluded that adding the PARP inhibitor niraparib to pembrolizumab as maintenance therapy did not improve progression-free survival or other efficacy outcomes for patients with advanced or metastatic NSCLC. The median PFS was 5.55 months in both the combination and placebo arms, indicating no benefit for this strategy. ()
Phase 2
Consolidative Thoracic Radiotherapy With Atezolizumab Maintenance in Extensive-Stage Small Cell Lung Cancer: The Phase 2 TREASURE Randomized Clinical Trial (AIO-TRK-0320). The phase 2 TREASURE trial was prematurely terminated due to safety concerns, finding that adding consolidative thoracic radiotherapy (TRT) to atezolizumab maintenance in ES-SCLC increased severe adverse events and fatal outcomes without improving survival. This combination led to a numerically shorter median overall survival (6.7 vs. 13.4 months), likely due to radiation-induced lymphocyte depletion facilitating infections. ()
Phase 3
Nivolumab plus chemoradiotherapy followed by nivolumab with or without ipilimumab for untreated locally advanced stage III NSCLC: a randomized phase 3 trial. In a phase 3 trial for unresectable stage III NSCLC, adding nivolumab to concurrent chemoradiotherapy followed by consolidation with either nivolumab alone or nivolumab plus ipilimumab failed to improve progression-free or overall survival compared to the standard of care (durvalumab consolidation). The investigational arms were also associated with an increased incidence of pneumonitis. ()
Phase 1
Model-Informed Development of a Subcutaneous Formulation of Tislelizumab: Phase 1 Pharmacokinetics in Patients With Cancer. A phase 1 study combined with pharmacokinetic modeling has established that a 300 mg subcutaneous dose of tislelizumab administered to the thigh achieves comparable drug exposure to the approved 200 mg intravenous dose. This model-informed approach supports the selection of the subcutaneous thigh injection for phase 3 evaluation, offering a more convenient administration option for patients. ()
Phase 2
Early ctDNA Stratifies Survival in Locally Advanced and Oligometastatic Lung Cancer Treated with Radiotherapy. A prospective phase II trial demonstrated that a machine learning-derived circulating tumor DNA (ctDNA) metric can robustly stratify risk in patients with locally advanced and oligometastatic NSCLC undergoing radiotherapy. Both pre-treatment and early on-treatment ctDNA burden strongly predicted overall and progression-free survival, supporting its use as a practical biomarker for treatment adaptation. ()
Phase 3
Surgical Outcomes of Perioperative Toripalimab in Stage III Resectable Non-Small Cell Lung Cancer: Post Hoc Analysis of the Neotorch Randomized Clinical Trial. A post hoc analysis of the phase 3 Neotorch trial found that perioperative toripalimab plus chemotherapy significantly improved tumor and lymph node downstaging compared to chemotherapy alone in resectable stage III NSCLC. This led to a lower rate of surgery cancellation and was associated with better event-free survival, without increasing surgical complications. ()
Phase 2
Efficacy and biomarker exploration of anlotinib plus penpulimab in second-line ES-SCLC: Results from the phase 2 ALTER-L041 trial. The combination of anlotinib plus penpulimab demonstrated promising antitumor activity as a second-line treatment for platinum-resistant extensive-stage SCLC in a phase 2 trial. The regimen achieved a confirmed objective response rate of 41.5% and a median overall survival of 10.5 months with a manageable safety profile, suggesting it as a potential new therapeutic option. ()
PHASE1, PHASE2
Personalized tumor-loaded monocyte-derived dendritic cell vaccination in combination with atezolizumab as maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC): phase Ib-II VENEZOLUNG trial. The phase Ib-II VENEZOLUNG trial showed that a personalized dendritic cell (DC) vaccine combined with atezolizumab maintenance for ES-SCLC was well-tolerated and suggested a potential for long-term survival benefit. Improved outcomes were associated with the expansion of specific immune cell populations (cDC1s and stem-like CD8+ T cells), highlighting a promising immunotherapeutic strategy. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in small cell lung cancer updated from 2026-07-01 to 2026-07-31:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation--1---1
Not Yet Recruiting5412-4126
Recruiting342428212-100
Available-------
Approved for Marketing-------
Active, Not Recruiting161533324-91
Completed231-3-9
Total5746755431227
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
TT125-802 NCT06403436 COMPLETED A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors 2026-06-30
Tretinoin, : Atezolizumab NCT04919369 COMPLETED A Phase Ib Dose De-Escalation Study of All-Trans Retinoic Acid (ATRA) and Atezolizumab in Patients With Advanced Non-Small Cell Lung Cancer 2026-07-03
[14C]Zorifertinib Oral Formulation NCT07620951 RECRUITING Phase I Clinical Study on Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China 2026-08
RAD301 ([68Ga]-RAD301) NCT05799274 RECRUITING Characterizing the Radiochemical and Radiation Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Ductal Adenocarcinoma or Other Solid Tumors 2026-08
Carboplatin, Cisplatin, Nab-paclitaxel, Sasanlimab, Oxaliplatin, Paclitaxel, Fluorouracil, Leucovorin, Pembrolizumab, pemetrexed, Cetuximab, Bevacizumab, Gemcitabine, PF-07934040 NCT06447662 ACTIVE_NOT_RECRUITING A Phase 1 Open-Label Study of PF-07934040 as a Single Agent and in Combination With Other Targeted Agents in Participants With Advanced Solid Tumors Harboring Mutations in the KRAS Gene 2026-10-09
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Canakinumab, Durvalumab, Chemotherapy NCT04905316 COMPLETED Phase I/II Study of Canakinumab With Chemoradiation and Durvalumab for Unresected Locally-Advanced Non-Small Cell Lung Cancer (CHORUS) 2026-07-06
: Ipilimumab, Cabozantinib S-malate, : Nivolumab NCT04079712 ACTIVE_NOT_RECRUITING A Phase 2 Study of XL184 (Cabozantinib) in Combination With Nivolumab and Ipilimumab for the Treatment of Poorly Differentiated Neuroendocrine Carcinomas 2026-08-19
Tepotinib NCT02864992 ACTIVE_NOT_RECRUITING A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION) 2026-08-31
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Carboplatin, Cisplatin, Placebo, Paclitaxel, Retifanlimab, nab-Paclitaxel, Pemetrexed NCT04205812 COMPLETED A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304) 2026-05-28
AMG 510, Docetaxel NCT04303780 COMPLETED A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C 2026-06-24
4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab, 4cycles(Placebo + platinum-based doublet chemotherapy)+13 cycles(Placebo ) NCT04158440 COMPLETED A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer 2026-07-03
Pemetrexed, Cisplatin, SYS6010, Carboplatin NCT06927986 RECRUITING A Randomized, Open-label, Multi-center, Phase III Clinical Study Comparing SYS6010 With Platinum-based Chemotherapy in the Treatment of EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of EGFR TKI Treatment 2026-08-30
SB27, Keytruda NCT06348199 ACTIVE_NOT_RECRUITING A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 (Proposed Pembrolizumab Biosimilar) and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer 2026-09
: Pembrolizumab, Pemetrexed, Cisplatin, Gemcitabine NCT03425643 ACTIVE_NOT_RECRUITING A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671) 2026-10-15
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
No phase 4 trials completing within the next three months.
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