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SCLCSeptember 2026
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Small Cell Lung Cancer — Monthly Compass
Sep 01–30, 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
    • SWOG S1827/MAVERICK demonstrated that brain MRI surveillance without PCI achieved superior cognitive failure–free survival with no apparent overall survival decrement, signaling immediate de‑implementation of PCI where MRI access is available.
  • Important Drug Publication Updates
    • The New England Journal of Medicine published TAISHAN‑302 data showing tambotatug pelitecan significantly improved overall survival in relapsed SCLC, reinforcing B7‑H3 ADC efficacy over topotecan.
  • Key Clinical Development Updates
    • Daiichi Sankyo and Merck voluntarily withdrew the US BLA for ifinatamab deruxtecan in previously treated ES‑SCLC after FDA feedback that phase 2 IDeate‑Lung01 and other evidence did not meet accelerated‑approval requirements, despite prior Priority Review with an October 10, 2026 target action date, while enrollment continues in the phase 3 IDeate‑Lung02 versus physician’s‑choice chemotherapy to inform a potential future filing.
    • Following a successful FDA Type C meeting, IDEAYA aligned on a registrational phase 3 for IDE849 (DLL3 TOP1 ADC) in post‑tarlatamab ES‑SCLC with BICR‑assessed ORR as a potential accelerated‑approval endpoint and OS for potential full approval, targeting ~400 patients randomized versus investigator’s‑choice chemotherapy with initiation by year‑end 2026.
  • Key Conference Updates
    • At WCLC 2026, the phase III DeLLphi‑305 interim analysis showed durvalumab plus tarlatamab delivered statistically significant and highly clinically meaningful improvements in overall survival and progression‑free survival over durvalumab alone as first‑line ES‑SCLC maintenance with no new safety signals.
    • Presidential sessions reported two phase III B7‑H3 ADCs—TAISHAN‑302 (tambotatug pelitecan) and ARTEMIS‑008 (risvutatug rezetecan)—achieving survival superiority versus topotecan in relapsed SCLC with global relevance and near‑term China access indicated by NMPA BLA acceptance for risvutatug rezetecan.
  • Emerging Themes & Macro-Trends
    • Subcutaneous and extended‑interval tarlatamab dosing (DeLLphi‑308/309) maintained exposure and activity with favorable safety while reducing or eliminating post‑dose monitoring, enabling operational scalability in community and resource‑constrained settings.
    • Intensifying competition between DLL3 T‑cell engagers and B7‑H3 ADCs, coupled with China‑first ADC access, is poised to shape global launch sequencing and market dynamics.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-09-01 and 2026-09-30 about small cell lung cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • IDEAYA Biosciences reported that a successful FDA Type C meeting aligned on a phase 3 registrational trial design for IDE849 (DLL3 TOP1 ADC) in post‑tarlatamab extensive‑stage SCLC, aiming for a seamless pathway with ORR (BICR) to support potential accelerated approval and OS to support potential full approval. The company plans to initiate the randomized study (~400 patients vs investigator’s choice chemotherapy) by year‑end 2026.¹ (read more)
  • Daiichi Sankyo and Merck voluntarily withdrew their US BLA seeking accelerated approval for ifinatamab deruxtecan (I‑DXd; B7‑H3 ADC) in previously treated extensive‑stage SCLC after FDA feedback that the phase 2 IDeate‑Lung01 data and other evidence did not meet accelerated‑approval requirements. Enrollment continues in the phase 3 IDeate‑Lung02 trial comparing I‑DXd with physician’s‑choice chemotherapy to inform a potential future filing.² (read more)
  • Targeted Oncology reported the I‑DXd BLA withdrawal, noting the application had previously received FDA Priority Review with an October 10, 2026 target action date, and summarizing FDA’s view that phase 2 IDeate‑Lung01 results were insufficient for accelerated approval. The article also highlights the ongoing phase 3 IDeate‑Lung02 study in relapsed ES‑SCLC.³ (read more)
Conference
Major Conference Updates
Conference Information
  • IASLC 2026 World Conference on Lung Cancer (WCLC); Seoul, Republic of Korea; September 12–15, 2026.
  • Sentiment: SCLC saw three concurrent inflection points—frontline DLL3 x PD‑L1 maintenance showing survival benefit, B7‑H3 ADCs outperforming topotecan in relapse, and de-implementation of PCI—together signaling an imminent overhaul of pathways across lines of therapy. (read more)
  • Theme 1: Frontline DLL3 x PD‑L1 Maintenance Emerges
    • Significance: Positive Phase III DeLLphi‑305 positions IMFINZI (durvalumab) + tarlatamab to redefine 1L ES‑SCLC maintenance beyond PD‑L1 monotherapy. (read more)
    • Mechanism insights / clinical impact: Combining PD‑L1 blockade with a DLL3‑directed T‑cell engager deepens anti‑tumor immunity; interim analysis showed statistically significant, clinically meaningful OS and PFS gains over durvalumab alone with no new safety signals. (read more)
    • Patient populations affected: ES‑SCLC patients without progression after induction durvalumab + platinum/etoposide; global maintenance setting. (read more)
  • Theme 2: B7‑H3 Antibody‑Drug Conjugates Reshape Relapsed Disease
    • Significance: Two randomized Phase III trials reported survival superiority vs topotecan—TAISHAN‑302 (tambotatug pelitecan/Tam‑Peli, YL201) and ARTEMIS‑008 (risvutatug rezetecan/Ris‑Rez)—marking ADCs as the leading contenders to replace cytotoxic SOC in 2L+. (read more)
    • Mechanism insights / clinical impact: B7‑H3–targeted ADCs exploit high tumor/microenvironment expression with limited normal‑tissue presence, delivering cytotoxic payloads that improved OS, PFS and ORR in WCLC presidential sessions; NEJM publication reinforces Tam‑Peli efficacy. (read more)
    • Patient populations affected: Relapsed SCLC post‑platinum ± PD‑L1; Chinese population for TAISHAN‑302 with broader global relevance via convergent ARTEMIS‑008 results; near‑term China access signaled by NMPA BLA acceptance for Ris‑Rez. (read more)
  • Theme 3: MRI Surveillance Displaces PCI
    • Significance: SWOG S1827/MAVERICK demonstrated superior cognitive failure–free survival for MRI surveillance without PCI and no apparent OS decrement—an immediate practice‑change signal. (read more)
    • Mechanism insights / clinical impact: Avoids neurotoxicity from whole‑brain irradiation while enabling timely detection/salvage; plenary positioning underscores cross‑disciplinary acceptance. (read more)
    • Patient populations affected: SCLC across stages enrolled (limited and extensive); broad applicability in institutions with MRI access. (read more)
  • Theme 4: Making DLL3 T‑cell Engagers Easier to Give (SC and Extended‑Interval)
    • Significance: DeLLphi‑308 (subcutaneous) and DeLLphi‑309 (q3–4w IV) aim to reduce chair time and monitoring burden—key to scaling access. (read more)
    • Mechanism insights / clinical impact: SC dosing achieved exposures comparable to approved IV with favorable safety and eliminated post‑dose monitoring in Part 2; extended‑interval IV showed consistent activity/safety vs q2w with CRS/ICANS largely low‑grade. (read more)
    • Patient populations affected: Previously treated ES‑SCLC; community and resource‑constrained centers likely to benefit most from simplified administration. (read more)
  • Significance
    • Expected clinical or translational readouts: Full DeLLphi‑305 dataset presentation and details on depth/duration of benefit; additional B7‑H3 ADC subgroup and safety analyses at upcoming meetings. (read more)
    • Regulatory or policy implications: Amgen/AZ plan global regulatory engagement for DeLLphi‑305; NMPA BLA already accepted for risvutatug rezetecan. PCI guidelines likely to revisit surveillance‑only strategies. (read more)
    • Potential shifts in standard of care: 1L ES‑SCLC maintenance could evolve to durvalumab + tarlatamab; in relapse, B7‑H3 ADCs may supersede topotecan. PCI may be de‑emphasized in favor of MRI surveillance. (read more)
    • Strategic implications: Intensifying competition between DLL3 engagers and B7‑H3 ADCs; delivery innovations (SC/extended‑interval) improve real‑world adoption and market penetration; access differentials (China-first ADCs) may shape global launch sequencing. (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 exhibited substantially worse survival outcomes and received limited benefit from immunotherapy, underscoring the need to develop novel therapeutic strategies for this high-risk patient subgroup. (, )
Phase 3
durvalumab
Population Pharmacokinetics and Exposure-response Analysis of Durvalumab in Patients with Limited-stage Small-cell Lung Cancer in the Phase 3 ADRIATIC Study. This pharmacokinetic analysis from the Phase 3 ADRIATIC study supports the use of durvalumab monotherapy as a consolidation treatment for limited-stage small-cell lung cancer (LS-SCLC). The findings demonstrate a flat exposure-response relationship for both efficacy and safety, confirming that the 1500 mg IV Q4W dose is appropriate and does not require adjustments based on patient-specific factors. ()
New Publications Related to Drugs in Clinical Trial Development
Phase 2
Single-arm, multicentre phase II trial of sintilimab plus platinum-based doublet chemotherapy followed by adaptive radiotherapy strategy for patients with unresectable stage III non-small-cell lung cancer in China: the ART-LUNG 01 study protocol. This publication details the study protocol for a phase II trial evaluating the efficacy and safety of sintilimab combined with induction chemotherapy, followed by adaptive radiotherapy and consolidation sintilimab. The trial aims to optimize the integration of immunotherapy and chemoradiotherapy for unresectable stage III NSCLC, particularly for patients with large tumors. ()
Phase 3
Tambotatug Pelitecan in Small-Cell Lung Cancer after Platinum-Based Therapy. In a pivotal phase 3 trial for relapsed small-cell lung cancer, the antibody-drug conjugate tambotatug pelitecan significantly improved overall survival to 13.3 months versus 9.4 months for topotecan. This therapy also demonstrated superior progression-free survival and objective response rates with a better safety profile, positioning it as a potential new second-line standard of care. ()
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 FAK inhibitor ifebemtinib plus KRASG12C inhibitor garsorasib showed an encouraging 82% objective response rate and a manageable safety profile in first-line KRASG12C-mutated NSCLC. These promising results have prompted the initiation of a randomized phase 3 study to confirm its efficacy against the current standard of care. ()
PHASE1, PHASE2
Daraxonrasib for Previously Treated <i>RAS</i>-Mutant Non-Small-Cell Lung Cancer. The oral RAS(ON) multi-selective inhibitor daraxonrasib demonstrated meaningful antitumor activity, achieving an objective response in over 30% of patients with previously treated advanced <i>RAS</i>-mutant NSCLC. While grade 3 or higher adverse events occurred in 54% of patients, the findings establish clinical proof-of-concept for this agent in a challenging patient population. ()
Phase 2
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. The SAVANNAH study successfully identified optimal MET biomarker cutoffs (IHC3+/≥90% and/or FISH10+) for selecting patients with EGFR-mutated NSCLC who are most likely to benefit from savolitinib plus osimertinib after progressing on first-line osimertinib. This analysis highlights the critical importance of precise biomarker selection to guide targeted therapy in the resistance setting. ()
Phase 2
Population Pharmacokinetics and Exposure-Response Analyses of Savolitinib Alone or in Combination With Osimertinib in Patients With Locally Advanced or Metastatic Solid Tumors. A comprehensive population pharmacokinetics analysis across 10 clinical studies confirmed that no patient covariates had a clinically meaningful impact on savolitinib exposure, supporting the current dosing strategy. Exposure-response data from the SAVANNAH study further validated the savolitinib dose in combination with osimertinib, especially in patients with high MET biomarker status. ()
Phase 3
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. In the first phase 3 cooperative group trial for inoperable early-stage NSCLC, adding atezolizumab to stereotactic body radiation therapy (SBRT) did not improve overall survival. The combination therapy was also associated with a higher incidence of grade 3 or higher adverse events, challenging the role of this immunotherapy strategy in the early-stage setting. ()
PHASE1, PHASE2
FAK inhibitor and RAF/MEK clamp avutometinib enhance KRAS G12C inhibitor efficacy in preclinical models of non-small cell lung cancer. Preclinical findings demonstrate that a triplet combination of a KRAS G12C inhibitor (sotorasib), a RAF/MEK clamp (avutometinib), and a FAK inhibitor (defactinib) significantly enhances antitumor activity and overcomes resistance in KRAS G12C-mutated NSCLC models. This provides a strong scientific rationale for the clinical evaluation of this triplet regimen in the RAMP 203 trial. ()
Phase 2
Trastuzumab Deruxtecan in Patients From China With Pretreated HER2-Mutant Non-Small Cell Lung Cancer: Final Analysis of the Phase 2, Single-Arm DESTINY-Lung05 Trial. The final analysis of the DESTINY-Lung05 trial confirms that trastuzumab deruxtecan (T-DXd) delivers durable and clinically meaningful antitumor activity in Chinese patients with pretreated HER2-mutant metastatic NSCLC. With a confirmed objective response rate of 56.9% and a median overall survival of 21.0 months, these results affirm T-DXd as a standard of care for this patient population in China. ()
Phase 3
DESTINY-Lung06: trastuzumab deruxtecan and pembrolizumab as first-line treatment for HER2-overexpressing, PD-L1 TPS <50% NSCLC. This publication outlines the design of the DESTINY-Lung06 phase III trial, which will assess the efficacy and safety of trastuzumab deruxtecan plus pembrolizumab versus standard chemo-immunotherapy for first-line HER2-overexpressing NSCLC with low PD-L1 expression. This study aims to address a significant unmet need by evaluating a targeted therapy combination in a patient population with limited first-line options. ()
Phase 3
Matching-Adjusted Indirect Comparison of Tarlatamab for Patients with Platinum-Refractory or Platinum-Resistant Extensive-Stage Small-Cell Lung Cancer. An indirect comparison leveraging data from the DeLLphi-304 trial suggests that tarlatamab is associated with significantly longer overall survival compared to paclitaxel or a cyclophosphamide, doxorubicin, and vincristine (CAV) regimen in second-line platinum-resistant extensive-stage SCLC. These findings support the potential of tarlatamab as a superior treatment option in this difficult-to-treat setting. ()
Phase 2
Prolonged survival after systemic immune reactivation by aglatimagene besadenovec plus valacyclovir in immune checkpoint inhibitor-refractory non-small cell lung cancer. In a phase 2a study for patients with NSCLC who progressed on immune checkpoint inhibitors, the in-situ vaccine aglatimagene besadenovec plus valacyclovir demonstrated encouraging survival, with a median overall survival of 24.5 months in the per-protocol population. The treatment induced systemic immune activation with a manageable safety profile, supporting its further investigation in a randomized controlled trial. ()
Phase 2
Genomic Profiling of Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer after Progression on First-line Osimertinib: Phase II ORCHARD Study. The ORCHARD study provides a comprehensive genomic analysis of EGFR-mutated NSCLC following progression on first-line osimertinib, revealing that 87% of tumors develop detectable resistance alterations, with nearly half harboring multiple mechanisms. This highlights the profound heterogeneity of resistance and provides a strong rationale for developing combination treatment strategies to improve patient outcomes. ()
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 using data from the TRUST-I and TRUST-II studies indicates that the next-generation TKI taletrectinib is associated with superior response and survival outcomes compared to first-generation TKIs like crizotinib and entrectinib in TKI-naïve ROS1+ NSCLC. This analysis supports taletrectinib as a highly effective first-line treatment option for this patient population. ()
Phase 2
Deulorlatinib (TGRX-326) in ALK Gene Fusion Positive NSCLC After Failure of Second-Generation Inhibitors: A Single-Arm, Multicenter, Phase 2 Trial. The third-generation ALK inhibitor deulorlatinib showed robust antitumor activity, with an objective response rate of 43.7% and a median PFS of 11.1 months, in patients with ALK-positive NSCLC who had progressed on second-generation inhibitors. With a favorable safety profile and notable intracranial efficacy, deulorlatinib represents a promising new therapeutic option for this patient population, including those with the G1202R mutation. ()
Phase 3
Osimertinib With or Without Chemotherapy in Advanced Non-Small Cell Lung Cancer With EGFR and Concurrent TP53 Mutations: A Randomized Clinical Trial. This phase 3 trial demonstrated that first-line osimertinib plus chemotherapy significantly extended median progression-free survival to 34.0 months, compared to 15.6 months with osimertinib alone, for patients with EGFR-mutated advanced NSCLC harboring concurrent TP53 mutations. These findings establish a clinical rationale for an individualized combination strategy in this high-risk patient subgroup. ()
Phase 3
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. The HARMONi phase 3 trial demonstrated that adding ivonescimab to chemotherapy resulted in a statistically significant and clinically meaningful improvement in progression-free survival (6.8 vs 4.4 months) for patients with EGFR-mutated NSCLC who progressed on third-generation EGFR-TKI therapy. This combination, with no new safety signals, is a potential new treatment option for this patient population. ()
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 using data from the TRUST-I and TRUST-II studies indicates that the next-generation TKI taletrectinib is associated with superior response and survival outcomes compared to first-generation TKIs like crizotinib and entrectinib in TKI-naïve ROS1+ NSCLC. This analysis supports taletrectinib as a highly effective first-line treatment option for this patient population. ()
Phase 3
SKYSCRAPER-02C: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage SCLC in China. While the global SKYSCRAPER-02 study was negative, this analysis of the Chinese cohort with extensive-stage SCLC showed numerical improvements in progression-free and overall survival with the addition of the TIGIT inhibitor tiragolumab to atezolizumab and chemotherapy. Biomarker analysis identified immune-inflamed signatures that may help guide future patient selection for TIGIT-based strategies. ()
Phase 2
A phase II multi-institutional single arm trial evaluating TG4010 vaccine plus nivolumab in non-small cell lung cancer. The combination of the MUC1 vaccine TG4010 with nivolumab demonstrated limited clinical benefit in a phase II trial of ICI-naïve NSCLC patients, with only one of twelve evaluable patients responding. Despite being well-tolerated, the lack of T cell clonal expansion or epitope spreading may explain the limited efficacy, suggesting this combination is not broadly effective. ()
Phase 3
Population Pharmacokinetic Comparability of CT-P16 Versus EU-Avastin® and US-Avastin® in Healthy Subjects and Patients with Non-Squamous Non-Small Cell Lung Cancer. An integrated population pharmacokinetic model confirmed that the bevacizumab biosimilar CT-P16 has comparable pharmacokinetics to both EU- and US-sourced reference Avastin®. This analysis adds to the totality of evidence supporting biosimilarity and demonstrates how PK modeling can streamline biosimilar drug development. ()
Phase 2
PD-L1 PET/CT imaging with 18F-BMS-986,229 and 18F-BMS-986,192 in patients with advanced-stage non-small cell lung cancer. This study found that two novel PD-L1 PET tracers performed equally but did not correlate with PD-L1 expression by immunohistochemistry in advanced NSCLC. However, an exploratory analysis suggested that low tumor tracer uptake may be associated with shorter overall survival, indicating a potential prognostic role for PD-L1 imaging that warrants further investigation. ()
Phase 2
Matching-Adjusted Indirect Comparison of Tarlatamab for Patients with Platinum-Refractory or Platinum-Resistant Extensive-Stage Small-Cell Lung Cancer. An indirect comparison leveraging data from the DeLLphi-304 trial suggests that tarlatamab is associated with significantly longer overall survival compared to paclitaxel or a cyclophosphamide, doxorubicin, and vincristine (CAV) regimen in second-line platinum-resistant extensive-stage SCLC. These findings support the potential of tarlatamab as a superior treatment option in this difficult-to-treat setting. ()
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 Neotorch trial revealed that perioperative toripalimab plus chemotherapy significantly improved tumor and lymph node downstaging in resectable stage III NSCLC compared to chemotherapy alone, without increasing surgical complications. This enhanced downstaging was strongly associated with better event-free survival, reinforcing the benefits of this neoadjuvant immuno-chemotherapy approach. ()
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 TREASURE trial was stopped early due to safety concerns, as combining consolidative thoracic radiotherapy with atezolizumab maintenance in extensive-stage SCLC led to increased severe and fatal adverse events, primarily infections. This combination did not improve survival, cautioning against its use in unselected patients and highlighting the potential for radiation-induced lymphocyte depletion to increase toxicity. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in small cell lung cancer updated from 2026-09-01 to 2026-09-30:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation-------
Not Yet Recruiting6621-8243
Recruiting4848587452208
Available-------
Approved for Marketing-------
Active, Not Recruiting2617392271112
Completed421-2-9
Total84731199825372
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
AI-061 NCT05858736 COMPLETED Safety, Pharmacokinetics (PK) and Efficacy of AI-061, A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC-392 (Anti-CTLA-4) Antibodies in Advanced Solid Tumors: An Open-Label Phase 1 Study 2026-07-31
[14C]Zorifertinib Oral Formulation NCT07620951 COMPLETED Phase I Clinical Study on Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China 2026-08-03
RAD301 ([68Ga]-RAD301) NCT05799274 ACTIVE_NOT_RECRUITING Characterizing the Radiochemical and Radiation Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Ductal Adenocarcinoma or Other Solid Tumors 2026-09
: PRTH-101, : Pembrolizumab NCT05753722 COMPLETED An Open-Label Phase 1 Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of PRTH-101 Alone or in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors 2026-09-02
BMS-986489 NCT06799286 COMPLETED An Open-label, Single-arm, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BMS-986489 (BMS-986012 + Nivolumab Fixed Dose Combination) in Chinese Participants With Relapsed/Refractory Small Cell Lung Cancer 2026-09-09
Fluorouracil, Nab-paclitaxel, Carboplatin, Gemcitabine, Pembrolizumab, Leucovorin, pemetrexed, Cisplatin, Bevacizumab, Sasanlimab, Cetuximab, Paclitaxel, Oxaliplatin, 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
[89Zr]Zr- BI 770371, Ezabenlimab, BI 770371, [89Zr]Zr- BI 765063, BI 765063 NCT05068102 ACTIVE_NOT_RECRUITING An Open Label Phase I PET Imaging Study to Investigate the Bio-distribution and Tumor Uptake of [89Zr]Zr-BI 765063 and [89Zr]Zr-BI 770371 in Patients With Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer or Melanoma Who Are Treated With Ezabenlimab 2026-11-25
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
PD-1/PD-L1 inhibitor plus chemotherapy NCT06501378 COMPLETED Cranial Radiotherapy Plus PD-1/PD-L1 Inhibitors and Chemotherapy in Untreated Driver-mutation Negative Non-small Cell Lung Cancer With Active Brain Metastasis (BRILLIANT-1) 2026-09-01
: Pembrolizumab NCT04032418 ACTIVE_NOT_RECRUITING Randomized Phase II Study of Pembrolizumab 200mg every12 Weeks Versus Every 3 Weeks in NSCLC With Clinical Benefit to Pembrolizumab Monotherapy: Multicenter International Study 2026-09-14
Gemcitabine+cisplatin, Nab-paclitaxel+carboplatin, Placebo for Olaparib, Pemetrexed+cisplatin, Durvalumab, Gemcitabine+carboplatin, Pemetrexed+carboplatin, Olaparib NCT03775486 ACTIVE_NOT_RECRUITING A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab Plus Olaparib Combination Therapy Compared With Durvalumab Monotherapy as Maintenance Therapy in Patients Whose Disease Has Not Progressed Following Standard of Care Platinum-Based Chemotherapy With Durvalumab in First Line Stage IV Non Small Cell Lung Cancer (ORION) 2026-09-27
INCB099280 NCT05879822 ACTIVE_NOT_RECRUITING A Phase 2 Study Evaluating INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive 2026-09-30
Cobimetinib, Atezolizumab NCT03600701 ACTIVE_NOT_RECRUITING A Phase 2 Study of Atezolizumab and Cobimetinib in PD-1/PD-L1 Inhibitor Resistant or Refractory Non-Small Cell Lung Cancer 2026-10-03
Adagrasib NCT05673187 ACTIVE_NOT_RECRUITING A Multicentre, Single-arm Phase II Trial of Adagrasib in Patients With KRASG12C-mutant NSCLC, Including the Elderly (≥70 Years) or Patients With Poor Performance Status 2026-12
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Gemcitabine, Cisplatin, Atezolizumab, Docetaxel, Vinorelbine, Pemetrexed NCT02486718 COMPLETED A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer 2026-08-26
MEDI4736 NCT02273375 COMPLETED A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer 2026-09-01
JDQ443, docetaxel NCT05132075 ACTIVE_NOT_RECRUITING A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer 2026-10-03
Avelumab NCT03815643 ACTIVE_NOT_RECRUITING An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies 2026-11-24
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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