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SCLCApril 2026
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Small Cell Lung Cancer — Monthly Compass
Apr 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
    • Lurbinectedin plus atezolizumab received regulatory approvals as first-line maintenance therapy for extensive-stage SCLC in Australia and Singapore via FDA’s Project Orbis, introducing a new maintenance standard in those markets.
  • Important Drug Publication Updates
    • An FDA Approval Summary reported accelerated approval of tarlatamab in ES‑SCLC progressing after platinum with a 40% overall response rate and 9.7‑month median duration of response, alongside boxed warnings for serious cytokine release syndrome and neurologic toxicity requiring vigilant management.
  • Key Clinical Development Updates
    • The FDA accepted and granted Priority Review under RTOR and Project Orbis for ifinatamab deruxtecan in previously treated ES‑SCLC with an October 10, 2026 PDUFA date, while new collaborations will test DLL3‑targeted combinations including zocilurtatug pelitecan with tarlatamab and obrixtamig with either zocilurtatug pelitecan or the PD‑L1/VEGF‑A bispecific pumitamig.
  • Important Clinical Trial Publications
    • In SKYSCRAPER‑02C, adding tiragolumab to atezolizumab plus chemotherapy in untreated ES‑SCLC produced numerical but not statistically significant improvements in progression‑free and overall survival, with exploratory immune‑inflamed signatures suggesting potential biomarker‑guided selection.
    • The Aurora B inhibitor AZD2811 showed modest antitumor activity (4.8% ORR) in relapsed/refractory SCLC, and longitudinal circulating tumor DNA effectively tracked response and early progression as a noninvasive monitoring tool.
  • Key Conference Updates
    • AACR 2026 spotlighted DLL3‑directed advances with zocilurtatug pelitecan achieving a 53.7% intracranial objective response rate (62.5% at 1.6 mg/kg) with manageable hematologic adverse events in ES‑SCLC with brain metastases, alongside emerging DLL3 radiotherapeutics (MP0712) and next‑generation T‑cell engager combinations on registrational paths.
  • Emerging Themes & Macro-Trends
    • Radioligand therapy expansion is driving dosimetry‑guided regulatory protocols, and dual‑DLL3 trials are poised to inform sequencing relative to lurbinectedin‑ or chemotherapy‑based care in ES‑SCLC.
    • Strategic focus is consolidating around DLL3‑anchored backbones (ADC plus T‑cell engager), IO‑angiogenesis co‑targets, DLL3 radiotherapeutic combinations, and companion diagnostics for DLL3/SSTR2 co‑expression.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-04-01 and 2026-04-30 about small cell lung cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Daiichi Sankyo and Merck reported that FDA accepted the BLA and granted Priority Review for ifinatamab deruxtecan (I‑DXd) in adults with previously treated ES‑SCLC; the review is also under RTOR and Project Orbis with a PDUFA target action date of October 10, 2026. The companies reiterated prior FDA Breakthrough Therapy designation (August 2025) and the BLA’s basis in IDeate‑Lung01 with support from IDeate‑PanTumor01. ¹ (read more)
  • CancerNetwork covered the FDA’s Priority Review of I‑DXd for ES‑SCLC after platinum therapy and noted the assigned PDUFA date of October 10, 2026. The article attributes the update to the sponsor’s press release and frames the filing as a potential new option in the post‑platinum setting. ² (read more)
  • Zai Lab announced a global clinical trial collaboration with Amgen to evaluate its DLL3‑targeting ADC zocilurtatug pelitecan (zoci; formerly ZL‑1310) plus IMDELLTRA (tarlatamab‑dlle) in ES‑SCLC. The company highlighted that zoci holds FDA Fast Track and Orphan Drug designations for SCLC. ³ (read more)
  • Boehringer Ingelheim and Zai Lab disclosed a separate clinical collaboration to test Boehringer’s DLL3/CD3 T‑cell engager obrixtamig with Zai Lab’s zoci in SCLC and other NECs. The update reiterated FDA Fast Track and Orphan Drug designations for the DLL3 programs as they advance toward registrational studies. ⁴ (read more)
  • Boehringer Ingelheim announced a collaboration with BioNTech to evaluate obrixtamig plus the PD‑L1/VEGF‑A bispecific pumitamig in ES‑SCLC, stating Boehringer will serve as regulatory sponsor of the Phase Ib/II trial. The release reiterated FDA Fast Track and Orphan Drug designations for obrixtamig and prior FDA Orphan Drug designation (2025) for pumitamig in SCLC. ⁵ (read more)
  • Specialised Therapeutics reported regulatory approvals of lurbinectedin (ZEPZELCA) plus atezolizumab as first‑line maintenance for ES‑SCLC in Australia and Singapore, obtained via FDA’s Project Orbis. The company emphasized Orbis’ role in aligning international reviews across participating agencies. ⁶ (read more)
  • A Clinical Cancer Research “FDA Approval Summary” detailed tarlatamab’s regulatory history in ES‑SCLC, noting the BLA submission (October 12, 2023) and FDA Priority Review leading to approval. The publication provides FDA’s assessment context and endpoints supporting the decision. ⁷ (read more)
Conference
Major Conference Updates
Conference Information
  • American Association for Cancer Research (AACR) Annual Meeting 2026; San Diego Convention Center, San Diego, California; April 17–22, 2026. (read more)
  • Overall sentiment: SCLC presentations centered on DLL3-directed modalities—ADCs with intracranial activity, next‑gen T‑cell engagers, and emerging radiotherapeutics—plus combination strategies to prolong benefit in ES‑SCLC. (read more)
  • Theme 1: DLL3‑Targeted ADCs Show CNS Activity and Late‑Line Potential
    • Significance: Heightened focus on overcoming brain metastases and cytotoxic delivery beyond chemotherapy standard options. (read more)
    • Mechanism insights / clinical impact: Zocilurtatug pelitecan (zoci, formerly ZL‑1310) is a DLL3‑targeted, topoisomerase‑I ADC reporting 53.7% intracranial ORR (62.5% at 1.6 mg/kg) with manageable hematologic AEs in ES‑SCLC with baseline brain metastases; pivotal “DLLEVATE” program ongoing. (read more)
    • Patient populations affected: Previously treated ES‑SCLC, especially patients with brain metastases; global development with registrational intent in 2L+ disease. (read more)
  • Theme 2: Dual‑Target and Microenvironment‑Modulating Combinations
    • Significance: Combinations aim to deepen and extend responses by coupling DLL3 cytotoxicity/T‑cell redirection with checkpoint/anti‑angiogenic control. (read more)
    • Mechanism insights / clinical impact: Obrixtamig (BI 764532; DLL3×CD3) + pumitamig (BNT327/BMS‑986545; PD‑L1×VEGF‑A) moves into Phase Ib/II; zoci + IMDELLTRA (tarlatamab‑dlle) global Phase 1b planned—positioning dual DLL3 strategies across lines; obrixtamig advancing to Phase 3 (DAREON‑Lung‑1). (read more)
    • Patient populations affected: First‑line ES‑SCLC (chemo‑IO backbones) and 2L+ DLL3‑positive disease across the U.S./EU/Asia. (read more)
  • Theme 3: DLL3 Radiotherapeutics Emerge (Alpha‑Emitter and Radio‑DARPin)
    • Significance: Radiopharmaceuticals promise antigen‑specific, receptor‑density‑agnostic killing and may address heterogeneous, treatment‑refractory SCLC. (read more)
    • Mechanism insights / clinical impact: MP0712, a 212Pb‑based Radio‑DARPin against DLL3, highlighted AACR translational data with supportive first‑patient imaging experience (203Pb); preclinical data suggest sustained uptake despite low DLL3 density; DLL3‑alpha therapy combinations with standard care show benefit preclinically. (read more)
    • Patient populations affected: DLL3‑expressing ES‑SCLC, including low‑antigen‑density and heavily pretreated cohorts. (read more)
  • Theme 4: Multispecific Platforms to Counter Heterogeneity
    • Significance: Co‑targeting aims to reduce antigen‑negative escape and broaden addressable SCLC subsets. (read more)
    • Mechanism insights / clinical impact: CS5008 (DLL3/SSTR2 bispecific ADC; exatecan payload) leverages co‑expression in SCLC/NECs; trispecific TCE GS24‑B047 (DLL3×CD3×CD2) seeks stronger synapse formation with tempered cytokine release. (read more)
    • Patient populations affected: DLL3/SSTR2‑coexpressing SCLC and extrapulmonary NECs in China and global expansion settings. (read more)
  • Significance
    • Expected clinical or translational readouts: Start of obrixtamig+pumitamig Phase Ib/II in 2H26; zoci+tarlatamab Phase 1b initiation; continued MP0712 clinical translation/dosimetry updates. (read more)
    • Regulatory or policy implications: Growing RLT footprint may accelerate dosimetry‑guided protocols; dual‑DLL3 trials could inform sequencing vis‑à‑vis lurbinectedin‑ or chemo‑based care. (read more)
    • Potential shifts in standard of care: If intracranial efficacy of zoci translates in pivotal trials and DLL3 TCE/ADC combinations extend durability, post‑platinum SCLC and even first‑line schemas could be re‑ordered toward DLL3‑anchored regimens. (read more)
    • Strategic implications: Prioritize DLL3 backbones (ADC+TCE) and IO‑angiogenesis co‑targets; advance radiotherapeutic combinations; build companion Dx around DLL3/SSTR2 co‑expression. (read more)
Publications Related to Approved Drugs
Phase 2
tarlatamab-dlle
FDA Approval Summary: Tarlatamab for the Treatment of Extensive-Stage Small Cell Lung Cancer. The FDA granted accelerated approval to tarlatamab for adult patients with extensive-stage small cell lung cancer progressing after platinum-based chemotherapy, based on an impressive 40% overall response rate and a median duration of response of 9.7 months in the DeLLphi-301 trial. Clinicians must remain vigilant regarding the boxed warnings for serious cytokine release syndrome and neurologic toxicity, necessitating careful patient monitoring and management strategies. ()
New Publications Related to Drugs in Clinical Trial Development
Phase 2
Decoding B-cell Signatures of Complete Pathologic Response to Perioperative Chemoimmunotherapy in Non-Small Cell Lung Cancer. Multiomic analysis of patients with resectable non-small cell lung cancer receiving perioperative chemoimmunotherapy revealed that a complete pathologic response is associated with a preexisting, more clonal B-cell receptor repertoire that matures during treatment. These findings highlight the critical role of B-cell responses and tertiary lymphoid structures in mediating efficacy, suggesting B-cell receptor metrics could serve as promising predictive biomarkers. ()
Phase 2
Long-Term Efficacy and Safety of Taletrectinib in Patients With <i>ROS1</i>+ Non-Small Cell Lung Cancer: Results From the Phase II TRUST-I Study. Long-term follow-up from the phase II TRUST-I study confirms that the next-generation ROS1 inhibitor taletrectinib delivers high, durable response rates and robust intracranial activity in both TKI-naïve and crizotinib-pretreated patients with advanced ROS1+ non-small cell lung cancer. The sustained efficacy, including a median progression-free survival exceeding 4 years in TKI-naïve patients, alongside a manageable safety profile, supports its use as a highly effective targeted therapy. ()
Phase 2
Durvalumab Plus Chemotherapy in Patients With <i>EGFR</i>-Mutated Advanced NSCLC Whose Disease Progressed on First-Line Osimertinib: ORCHARD. In the ORCHARD platform study, the combination of durvalumab plus platinum-based chemotherapy demonstrated limited clinical benefit in patients with EGFR-mutated advanced non-small cell lung cancer who progressed on first-line osimertinib. Despite being well tolerated, the low objective response rate of 16% indicates that this combination does not warrant further evaluation in this specific post-osimertinib setting. ()
Phase 3
Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer: final analysis of the randomized RATIONALE-315 trial. The final analysis of the phase III RATIONALE-315 trial demonstrated that perioperative tislelizumab combined with neoadjuvant chemotherapy significantly improved overall survival and event-free survival compared to chemotherapy alone in patients with resectable stage II-IIIA non-small cell lung cancer. These clinically meaningful survival benefits, coupled with a tolerable safety profile, strongly support this regimen as a standard-of-care option for this patient population. ()
Phase 2
Deulorlatinib (TGRX-326) in ALK gene fusion positive non-small cell lung cancer after failure of second-generation inhibitors (DRAGON): a single-arm, multicenter, phase 2 trial. The novel third-generation ALK inhibitor deulorlatinib demonstrated encouraging anti-tumor activity, including a 43.7% objective response rate and robust intracranial efficacy, in patients with advanced ALK-positive non-small cell lung cancer who progressed on second-generation inhibitors. Notably, it showed strong activity against the difficult-to-treat G1202R mutation and maintained a favorable safety profile, positioning it as a promising new therapeutic option. ()
Phase 3
Time-of-day immunochemotherapy in non-small cell lung cancer: a randomized phase 3 trial. The phase 3 LungTIME-C01 trial demonstrated that administering immunochemotherapy before 15:00 h significantly improved progression-free and overall survival compared to later administration in patients with treatment-naïve advanced non-small cell lung cancer. This early time-of-day approach was associated with enhanced circulating CD8+ T cell activation and reduced exhaustion, suggesting a simple, cost-free strategy to optimize immunotherapy efficacy. ()
Phase 3
SUNRAY-01 trial protocol: an innovative study design of olomorasib and pembrolizumab with or without chemotherapy in <i>KRAS</i> G12C NSCLC. The SUNRAY-01 trial is investigating the efficacy and safety of combining the novel KRAS G12C inhibitor olomorasib with pembrolizumab, with or without chemotherapy, in patients with advanced KRAS G12C-mutated non-small cell lung cancer. This innovative study design aims to evaluate whether dual targeting of the KRAS pathway and immune checkpoints can overcome resistance and improve clinical outcomes in this specific molecular subgroup. ()
Phase 1
First-Line Zongertinib in Advanced <i>HER2</i>-Mutant Non-Small-Cell Lung Cancer. In a phase 1b trial, the novel, irreversible, HER2-selective tyrosine kinase inhibitor zongertinib demonstrated a high confirmed objective response rate of 76% and a median progression-free survival of 14.4 months as a first-line treatment for advanced HER2-mutant non-small cell lung cancer. The drug also showed promising intracranial activity and a manageable safety profile, highlighting its potential to address a significant unmet need in this patient population. ()
Phase 1
Discovery of BBO-11818, a Potent and Selective Noncovalent Inhibitor of (ON) and (OFF) KRAS with Activity against Multiple Oncogenic Mutants. BBO-11818 is a novel, orally bioavailable, noncovalent pan-KRAS inhibitor that effectively targets multiple clinically relevant KRAS mutations, including G12D and G12V, in both their active and inactive states. Preclinical data demonstrate potent inhibition of MAPK signaling and tumor regression, supporting its ongoing phase I clinical evaluation as a versatile therapeutic option for KRAS-driven malignancies. ()
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 Small Cell Lung Cancer in China. In the SKYSCRAPER-02C trial evaluating Chinese patients with extensive-stage small cell lung cancer, the addition of the anti-TIGIT antibody tiragolumab to atezolizumab and chemotherapy showed numerical, though not statistically significant, improvements in progression-free and overall survival compared to the control arm. Exploratory biomarker analyses identified specific immune-inflamed signatures that may help select patients most likely to benefit from TIGIT-based combination strategies in the future. ()
Phase 2
Fecal microbiota transplantation plus immunotherapy in non-small cell lung cancer and melanoma: the phase 2 FMT-LUMINate trial. The phase 2 FMT-LUMINate trial demonstrated that healthy donor fecal microbiota transplantation (FMT) combined with first-line immune checkpoint inhibitors is safe and yields high objective response rates in patients with advanced non-small cell lung cancer and melanoma. Metagenomic analysis revealed that clinical benefit was associated with the depletion of specific deleterious bacterial species rather than simple donor strain engraftment, providing crucial insights for optimizing microbiome-based interventions. ()
Phase 2
FDG-PET/CT based small volume accelerated immuno chemoradiotherapy in locally advanced NSCLC (PACCELIO) - a randomized, open-label, multicenter phase II trial protocol. The PACCELIO phase II trial is evaluating whether integrating FDG-PET/CT to guide volume-reduced, hypofractionated chemoradiotherapy can improve treatment completion rates and facilitate successful transition to consolidation durvalumab in patients with inoperable stage III non-small cell lung cancer. This approach aims to enhance locoregional control while minimizing toxicity, potentially establishing a new, optimized standard of care for this challenging disease stage. ()
Phase 2
Baseline tumor burden and outcomes in patients with rare cancers treated with immunotherapy (Southwest Oncology Group trial S1609). In a large basket trial of rare cancers treated with dual immune checkpoint inhibitors, a larger baseline tumor burden was independently associated with worse overall survival, but not progression-free survival. However, baseline tumor burden was not predictive of tumor regression, suggesting it should be considered a prognostic rather than a predictive factor in this setting. ()
PHASE1, PHASE2
A Phase 1 dose-escalation study to evaluate safety, pharmacokinetics, and pharmacodynamics of OSE-279, an anti-PD-1 monoclonal antibody in patients with advanced solid tumours. The novel anti-PD-1 monoclonal antibody OSE-279 demonstrated a favorable safety profile, linear pharmacokinetics, and sustained high receptor occupancy in a phase 1 dose-escalation study involving patients with advanced solid tumors. The observation of durable objective responses supports its continued clinical development, including planned combination strategies such as therapeutic cancer vaccines in non-small cell lung cancer. ()
Phase 2
Phase 2 Study of Cabozantinib (XL184) with Nivolumab and Ipilimumab for the Treatment of Poorly Differentiated Neuroendocrine Carcinomas (ETCTN10315). A phase 2 trial evaluating the combination of cabozantinib, nivolumab, and ipilimumab in patients with previously treated, poorly differentiated neuroendocrine carcinomas was terminated early due to a low objective response rate of 12.5%. While the combination was generally tolerable and produced long-term responses in a small subset of patients, it did not meet the prespecified efficacy threshold to warrant further investigation in this unselected population. ()
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 phase II EVOKE-02 study demonstrated that first-line treatment with the Trop-2-directed antibody-drug conjugate sacituzumab govitecan, combined with pembrolizumab and carboplatin, yielded promising objective response rates in both nonsquamous and squamous metastatic non-small cell lung cancer. Following a dose reduction to 7.5 mg/kg to manage myelosuppression, the combination showed a tolerable safety profile, supporting further evaluation of this novel chemoimmunotherapy approach. ()
Phase 2
Alirocumab plus cemiplimab in advanced immuno-refractory metastatic non-small cell lung cancer: an ongoing multi-center phase II study. The TOP2201 phase II trial is investigating the novel combination of the PCSK9 inhibitor alirocumab and the anti-PD-1 therapy cemiplimab in patients with metastatic non-small cell lung cancer who have progressed on prior immune checkpoint blockade. Based on preclinical evidence that PCSK9 inhibition enhances antigen presentation, this study aims to determine if this strategy can overcome immunotherapy resistance and restore clinical benefit. ()
Phase 1
Treatment monitoring by biomarker analysis in a Phase I dose-expansion study of AZD2811 for relapsed/refractory small-cell lung cancer. In a phase I dose-expansion study, the Aurora kinase B inhibitor AZD2811 demonstrated modest preliminary antitumor activity in patients with relapsed/refractory small-cell lung cancer, with an objective response rate of 4.8%. Notably, longitudinal analysis of circulating tumor DNA effectively mirrored clinical responses and identified early progression, suggesting its potential utility as a non-invasive biomarker for personalized disease monitoring in this setting. ()
Phase 3
Participation in lung cancer biospecimen studies: an analysis of the ECOG-ACRIN phase 3 E1505 and E5508 clinical trials. An analysis of two large phase 3 lung cancer trials revealed that women, racial and ethnic minorities, and patients treated outside major academic centers are significantly less likely to participate in optional biospecimen studies. These disparities in biospecimen collection threaten the generalizability of translational research findings and highlight the need for targeted strategies to ensure diverse representation in biomarker-driven oncology studies. ()
Phase 3
Efficacy and safety of savolitinib in Chinese patients with locally advanced or metastatic <i>MET</i> exon 14-mutated non-small cell lung cancer: final results of a confirmatory Phase 3b study. Final results from a phase 3b confirmatory trial demonstrate that the MET inhibitor savolitinib provides robust and durable efficacy, with objective response rates of 42% in previously treated and 62% in treatment-naïve Chinese patients with MET exon 14-mutated advanced non-small cell lung cancer. The manageable safety profile and clinically meaningful survival outcomes solidify savolitinib as a standard targeted treatment option for this specific molecular subgroup. ()
Phase 2
Early ctDNA stratifies survival in locally advanced and oligometastatic lung cancer treated with radiotherapy. A novel, machine learning-derived circulating tumor fraction estimate (ctFE) from a tumor-naïve ctDNA assay effectively risk-stratified patients with locally advanced and oligometastatic non-small cell lung cancer undergoing radiotherapy. Both baseline and early on-treatment ctFE burden strongly predicted overall and progression-free survival, outperforming traditional metrics and offering a practical, noninvasive biomarker to guide precision treatment adaptation. ()
Phase 3
Four-Year Outcomes for Nivolumab With Chemotherapy and Bevacizumab in Patients With Nonsquamous NSCLC in the TASUKI-52. Four-year follow-up from the phase III TASUKI-52 trial confirms that the addition of nivolumab to carboplatin, paclitaxel, and bevacizumab provides sustained, long-term overall and progression-free survival benefits in patients with advanced nonsquamous non-small cell lung cancer. The durable responses and absence of new safety signals reinforce this combination as a highly effective first-line treatment option, particularly for patients younger than 65 and those without bone metastases. ()
Phase 1
Safety and Antitumor Activity of Farletuzumab Ecteribulin in Patients With NSCLC: Phase I Expansion Results. In a phase I expansion study, the folate receptor-alpha (FRα)-targeting antibody-drug conjugate farletuzumab ecteribulin demonstrated modest antitumor activity and a manageable safety profile in heavily pretreated patients with advanced non-small cell lung cancer. While the overall objective response rate was low, the activity observed in FRα-positive patients suggests potential utility for this targeted approach, warranting further investigation in biomarker-selected populations. ()
Phase 3
First-Line Cemiplimab for Locally Advanced NSCLC: Updated Subgroup Analyses From the EMPOWER-Lung 1 and EMPOWER-Lung 3 Trials. Updated subgroup analyses from two phase III trials demonstrate that first-line cemiplimab, either as monotherapy (for PD-L1 ≥50%) or combined with chemotherapy, significantly improves overall and progression-free survival compared to chemotherapy alone in patients with unresectable locally advanced non-small cell lung cancer who are ineligible for definitive chemoradiation. These findings, along with favorable patient-reported outcomes, support cemiplimab-based regimens as effective treatment options for this challenging patient population. ()
PHASE1, PHASE2
Fulzerasib plus cetuximab in first-line KRASG12C-mutated non-small-cell lung cancer (KROCUS): a single-arm, multicentre, phase 1b/2 trial. The combination of the KRAS G12C inhibitor fulzerasib and the anti-EGFR antibody cetuximab demonstrated a high confirmed objective response rate of 69% and a favorable safety profile as a first-line treatment for patients with KRAS G12C-mutated advanced non-small cell lung cancer. These encouraging results suggest that dual vertical pathway inhibition is a highly active strategy in this setting, supporting its advancement to phase 3 clinical trials. ()
Phase 4
Lorlatinib in patients with <i>ALK</i>-positive metastatic NSCLC previously treated with an ALK inhibitor: results from a phase IV study. A phase IV post-approval study confirmed the efficacy of lorlatinib in patients with ALK-positive metastatic non-small cell lung cancer who progressed on a prior second-generation ALK inhibitor, demonstrating a 42% objective response rate and robust intracranial activity. The safety profile remained consistent with earlier trials, reaffirming lorlatinib as a clinically meaningful treatment option for this previously treated patient population. ()
PHASE2, PHASE3
Tiragolumab Plus Atezolizumab and Chemotherapy for Advanced Nonsquamous Non-Small Cell Lung Cancer: The Phase 3 SKYSCRAPER-06 Randomized Clinical Trial. The phase 3 SKYSCRAPER-06 trial evaluating the addition of the anti-TIGIT antibody tiragolumab to atezolizumab and chemotherapy versus pembrolizumab and chemotherapy in first-line advanced nonsquamous non-small cell lung cancer was terminated early after failing to meet its primary endpoints. The combination did not improve progression-free or overall survival compared to the standard-of-care control arm, highlighting the challenges of improving upon current chemoimmunotherapy regimens in this setting. ()
Phase 1
Population-Based Modeling to Predict Human PK/PD of TAK-500, an Anti-CCR2 Antibody-Drug Conjugate for First-in-Human Study in Cancer Patients. A population pharmacokinetic-receptor occupancy model successfully integrated preclinical and clinical data to predict the human pharmacokinetics and target engagement of TAK-500, a novel anti-CCR2 antibody-drug conjugate. This quantitative framework provides a crucial foundation for guiding first-in-human dose selection and optimizing the clinical development of immune cell-directed ADCs. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in small cell lung cancer updated from 2026-04-01 to 2026-04-30:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation----1-1
Not Yet Recruiting3414-5-26
Recruiting5140504412188
Available-------
Approved for Marketing-------
Active, Not Recruiting2816352251107
Completed-15-1-7
Total82611046733329
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
PF-08046032, Sasanlimab NCT06870487 ACTIVE_NOT_RECRUITING An Open-Label Phase 1 Study to Evaluate PF-08046032 as Monotherapy and Part of Combination Therapy in Participants With Advanced Malignancies 2026-04-26
MEDI5752, Carboplatin, Durvalumab, AZD2936, AZD7789, Datopotamab deruxtecan NCT04612751 ACTIVE_NOT_RECRUITING A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Immunotherapy With or Without Carboplatin in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04) 2026-05-04
BG-60366 NCT06685718 ACTIVE_NOT_RECRUITING Phase 1a/1b, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of a CDAC Degrading EGFR, BG-60366, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer 2026-05-15
Osimertinib, Sapanisertib NCT02503722 ACTIVE_NOT_RECRUITING A Phase 1 Trial of MLN0128 (TAK-228) in Combination With Osimertinib (AZD9291) in Advanced EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC) After Progression on a Previous EGFR Tyrosine Kinase Inhibitor 2026-06-05
PF-08046049 NCT05571839 ACTIVE_NOT_RECRUITING A Phase 1 Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors 2026-06-06
S-1, RO7496353, Nab-paclitaxel, Capecitabine, Atezolizumab, Oxaliplatin, Gemcitabine, Nivolumab NCT05867121 ACTIVE_NOT_RECRUITING A Phase Ib, Open-label, Multicenter Dose-expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors 2026-06-30
Cisplatin, Elimusertib, Gemcitabine Hydrochloride NCT04491942 ACTIVE_NOT_RECRUITING A Phase 1 Trial of the ATR Inhibitor BAY 1895344 in Combination With Cisplatin and With Cisplatin Plus Gemcitabine in Advanced Solid Tumors With an Emphasis on Urothelial Carcinoma 2026-06-30
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Atezolizumab Injection; bevacizumab Injection NCT04147351 COMPLETED A Phase II Study of Atezolizumab in Combination With Bevacizumab, Carboplatin or Cisplatin, and Pemetrexed for EGFR-mutant Metastatic Non-small Cell Lung Cancer Patients After Failure of EGFR Tyrosine Kinase Inhibitors. 2026-02-04
IO102-IO103 in combination with pembrolizumab NCT05077709 COMPLETED A Phase II Multi-Arm (Basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination With Pembrolizumab, as First-Line Treatment for Patients With Metastatic NSCLC, SCCHN, or Metastatic mUBC 2026-02-08
Durvalumab NCT03589547 COMPLETED Durvalumab and Consolidation SBRT Following Chemoradiation for Locally Advanced Stage III Non-Small Cell Lung 2026-02-18
: Pembrolizumab NCT03634241 COMPLETED Single-Arm, Phase II of Immunotherapy With Pembrolizumab for the Prevention of Lung Cancer (IMPRINT-Lung) 2026-03-11
furmonertinib NCT06812871 COMPLETED A Single-arm, Multicenter, Phase 2 Study of High-dose Furmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Meningeal Metastasis 2026-03-30
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) 2026-04-30
Nab paclitaxel, Carboplatin, almonertinib NCT06300424 ACTIVE_NOT_RECRUITING Neoadjuvant Almonertinib Followed by Adebrelimab-based Chemo-immunotherapy in II-IIIB EGFR-mutant Non-small Cell Lung Cancer, a Single Arm, Phase II Study 2026-04-30
: Nivolumab NCT03110978 ACTIVE_NOT_RECRUITING Phase II Randomized Clinical Trials Comparing Immunotherapy Plus Stereotactic Ablative Radiotherapy (I-SABR) Versus SABR Alone for Stage I, Selected Stage IIa, or Isolated Lung Parenchymal Recurrent Non-Small Cell Lung Cancer: I-SABR 2026-06-30
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 2026-07
Osimertinib, : Bevacizumab NCT02971501 ACTIVE_NOT_RECRUITING A Phase II Trial of Osimertinib (AZD9291) With or Without Bevacizumab in Patients With EGFR Mutation Positive NSCLC and Brain Metastases 2026-07-01
Patritumab Deruxtecan (Up-Titration), Patritumab Deruxtecan (Fixed dose) NCT04619004 ACTIVE_NOT_RECRUITING HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) 2026-07-03
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Keytruda-EU, GME751 NCT06159790 COMPLETED A Randomized, Double-blind, Parallel-group Study to Compare Efficacy, Safety, and Immunogenicity of GME751 (Proposed Pembrolizumab Biosimilar) and EU-authorized Keytruda® in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) 2026-03-16
BL-B01D1, Pemetrexed+Cisplatin or Carboplatin NCT06382116 ACTIVE_NOT_RECRUITING A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Platinum Based Chemotherapy (First-line of Systemic Treatment) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After EGFR-TKI Failure 2026-05
Pemetrexed, : Pembrolizumab, Carboplatin, Nab-paclitaxel, Paclitaxel NCT06096844 RECRUITING A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult With Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study 2026-06-01
AMG 510, Docetaxel NCT04303780 ACTIVE_NOT_RECRUITING 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
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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