Clinical Trials for Small Cell Lung Cancer

A Phase 2 Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with measurable relapsed SCLC after failure of or intolerance to frontline platinum-based treatment, ECOG 0–2, and no more than two prior cytotoxic chemotherapy lines for extensive-stage disease receive single-agent oral onvansertib. Onvansertib is an investigational PLK1 inhibitor that disrupts mitosis.

ClinicalTrials.gov ID: NCT05450965

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with measurable recurrent or advanced/metastatic hepatocellular, cervical, melanoma, head and neck squamous, platinum-resistant high-grade serous ovarian, or non-small cell lung cancer and ECOG 0–1 receive DB-1311, a B7-H3–targeted topoisomerase I inhibitor antibody–drug conjugate. It is combined with either BNT327, a PD-L1/VEGF-A bispecific antibody, or DB-1305, a TROP2-targeted topoisomerase I inhibitor antibody–drug conjugate.

ClinicalTrials.gov ID: NCT06953089

An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with locally advanced or metastatic NSCLC and ECOG 0–1 are enrolled in first-line cohorts without known actionable alterations (PD-L1 ≥1%) or a second-line nonsquamous cohort with actionable alterations after progression on targeted therapy. First-line treatment is rilvegostomig (a PD-1/TIGIT bispecific antibody) with or without ramucirumab (anti-VEGFR2), depending on PD-L1 expression; second-line treatment is datopotamab deruxtecan (a TROP2-directed, topoisomerase I inhibitor–delivering antibody–drug conjugate) plus ramucirumab, with or without rilvegostomig.

ClinicalTrials.gov ID: NCT07098338

A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with locally advanced or metastatic NSCLC that progressed after at least six weeks of anti-PD-(L)1 therapy receive single-agent SAR445877 every 14 days. SAR445877 combines PD-1 blockade with a reduced-activity IL-15 complex designed to preferentially stimulate PD-1–expressing immune cells.

ClinicalTrials.gov ID: NCT07133425

KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial enrolls previously untreated patients with advanced or metastatic nonsquamous NSCLC harboring a KRAS G12C mutation. It compares pembrolizumab plus carboplatin/pemetrexed with pembrolizumab plus investigational calderasib (MK-1084), a covalent KRAS G12C inhibitor, with or without cetuximab.

ClinicalTrials.gov ID: NCT07252739

A Phase 2 Study to Investigate Ubamatamab With and Without REGN7075 in Treatment-Experienced Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: For patients with previously treated unresectable stage IIIB/IIIC or metastatic NSCLC and ECOG 0–1, this study evaluates ubamatamab, a MUC16 × CD3 T-cell–engaging bispecific antibody, with or without REGN7075, an EGFR × CD28 T-cell–costimulating bispecific antibody. Sarilumab is included to manage immune-related adverse effects.

ClinicalTrials.gov ID: NCT07154290

A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: For adults with previously untreated small cell lung cancer transformed from EGFR-mutated NSCLC after tyrosine kinase inhibitor therapy, this single-arm study combines chemotherapy with PF-08634404, an investigational bispecific antibody targeting PD-1 and VEGF. Treatment is followed by PF-08634404 maintenance; the chemotherapy regimen is not specified.

ClinicalTrials.gov ID: NCT07476287

An Open-Label Phase II Study of ILKN421H in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with ECOG 0–1, unresectable locally advanced or metastatic squamous or nonsquamous NSCLC without actionable EGFR/ALK/ROS1 alterations are eligible either after progression on PD-1/PD-L1 therapy regardless of PD-L1 status or untreated with PD-L1 TPS ≥1%. Patients receive pembrolizumab plus ILKN421H, an mRNA therapy encoding an albumin-fused, IL-2Rβ/γ-selective IL-2 variant designed to expand CD8 T and NK cells while avoiding IL-2Rα signaling.

ClinicalTrials.gov ID: NCT07452224

A Phase II Study of Ivonescimab as Monotherapy or in Combination With Platinum/Pemetrexed Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring Actionable Genomic Alterations (AGAs)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced or metastatic nonsquamous NSCLC harboring an EGFR sensitizing mutation or ALK, ROS1, RET, or NTRK fusion receive ivonescimab after genotype-appropriate targeted therapy and platinum/pemetrexed. A separate chemotherapy-naive cohort without EGFR-mutated disease receives ivonescimab plus carboplatin/pemetrexed after targeted therapy; ivonescimab is an investigational bispecific antibody targeting PD-1 and VEGF-A.

ClinicalTrials.gov ID: NCT07405190

A Phase 3, Multicenter, Randomized, Controlled, Open-Label Clinical Trial of Aglatimagene Besadenovec (CAN-2409) Plus Prodrug and Pembrolizumab Versus Docetaxel for Stage IV Non-Squamous Non-Small Cell Lung Cancer Progressing on Pembrolizumab-based Treatment

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with stage IV non-squamous NSCLC, ECOG 0–1, progressing after ≥12 weeks of pembrolizumab-based therapy and prior platinum chemotherapy, with an injectable thoracic lesion, are randomized to continued pembrolizumab plus intratumoral CAN-2409 and oral valacyclovir or docetaxel. CAN-2409 is a nonreplicating adenoviral vector encoding HSV thymidine kinase that activates valacyclovir metabolites to induce tumor-cell death and systemic antitumor immunity.

ClinicalTrials.gov ID: NCT07660094