Clinical Trials for Small Cell Lung Cancer

A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer

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 extensive-stage SCLC who achieved at least stable disease after 4–6 cycles of first-line platinum/etoposide plus atezolizumab or durvalumab receive maintenance PD-L1 inhibitor with or without iadademstat. Iadademstat is an oral covalent LSD1 (KDM1A) inhibitor that modulates SCLC neuroendocrine programs (e.g., activates NOTCH, suppresses ASCL1); treated/stable brain metastases and controlled HIV/HBV/HCV allowed.

ClinicalTrials.gov ID: NCT06287775

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

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 unresectable advanced/metastatic solid tumors (excluding HCC, sarcomas, gliomas) who have progressed on or are unsuitable for standard therapy receive PRTH-101, an anti‑DDR1 monoclonal antibody intended to disrupt collagen-mediated T‑cell exclusion, either as monotherapy or combined with pembrolizumab. Suitable for ECOG 0–1 with treated/stable CNS disease only; key exclusions include active autoimmune disease on immunosuppression, uncontrolled infections, and recent systemic therapy or radiation.

ClinicalTrials.gov ID: NCT05753722

A Phase Ib/II, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination With BNT327 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

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/metastatic NSCLC (squamous or non-squamous), including both first-line AGA-negative and previously treated patients (with genotype-specific prior therapy, e.g., post–third-gen EGFR TKI), receive the HER3-directed topoisomerase I ADC BNT326 combined with the PD-L1/VEGF-A bispecific antibody BNT327, with arms also testing each agent alone and standard-of-care comparators by PD-L1 status. Excludes prior HER3/topo I ADC exposure (with limited exceptions), uncontrolled ILD/pneumonitis, active CNS disease needing steroids/anticonvulsants, significant effusions, and high-grade prior irAEs leading to ICI discontinuation.

ClinicalTrials.gov ID: NCT07111520

A Phase 1b, Two-Part Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer

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/metastatic NSCLC (ECOG 0–1), excluding EGFR/ALK alterations, receive intratumoral tolododekin alfa (ANK-101), an anchored IL‑12 designed for localized immune activation, combined with an anti–PD-1/PD-L1 antibody. Includes two cohorts: post–PD-1/PD-L1 and platinum–pretreated patients receiving tolododekin alfa plus cetrelimab, and treatment‑naïve patients receiving tolododekin alfa plus investigator’s choice of approved PD-1/PD-L1 inhibitor; mandatory fresh biopsies.

ClinicalTrials.gov ID: NCT07027514

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

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, measurable solid tumors refractory to standard therapy (ECOG 0–1) receive oral TT125-802 monotherapy, a selective CBP/p300 bromodomain inhibitor targeting acetylation-dependent transcriptional programs. Dose-escalation with potential expansion assesses safety/PK and preliminary efficacy, with early activity signals reported in heavily pretreated NSCLC (including EGFR- and KRAS G12C–mutant).

ClinicalTrials.gov ID: NCT06403436

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE849 in Patients With DLL3-Expressing Tumors Including Small Cell Lung Cancer

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 relapsed/refractory DLL3-expressing small cell lung cancer after platinum chemotherapy and PD-1/PD-L1 therapy receive IDE849, a DLL3-directed antibody–drug conjugate delivering a topoisomerase I inhibitor. Open-label dose escalation and expansion enroll ECOG 0–1 patients with measurable disease; key exclusions include active/untreated CNS metastases and prior DLL3 or TOP1 inhibitor ADC exposure.

ClinicalTrials.gov ID: NCT07174583

A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination With Budigalimab (ABBV-181) in Adult Subjects With Advanced Squamous Tumors

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: Enrolling adults with advanced/metastatic squamous malignancies (including squamous NSCLC and head and neck SCC) that have progressed after or are not candidates for standard therapies, with measurable disease; prior PD-1/PD-L1 therapy is allowed and tumor tissue/biopsies are required for biomarker analyses in some cohorts. Patients receive oral ABBV-711 (mechanism/target not publicly disclosed) as monotherapy or in combination with budigalimab (ABBV-181), an engineered anti–PD-1 IgG1 monoclonal antibody.

ClinicalTrials.gov ID: NCT07241039

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer

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 metastatic NSCLC harboring KRAS G12C (ECOG 0–1) who have progressed on or are intolerant to platinum chemotherapy and PD-(L)1 therapy (no prior KRAS inhibitor; no other actionable driver alterations; stable/asymptomatic treated brain metastases allowed). Patients receive IV amivantamab (EGFR/MET bispecific antibody) in combination with oral olomorasib/LY3537982 (selective KRAS G12C inhibitor binding the GDP-bound mutant) until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT07227025

A Phase 2 Study of DRP-104, a Glutamine Antagonist, in Patients With NFE2L2/KEAP1-altered 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.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: Enrolling adults with advanced/metastatic or unresectable NSCLC harboring NFE2L2 or KEAP1 alterations who have RECIST-measurable disease and have progressed after prior platinum-based chemotherapy and anti–PD-1/PD-L1 therapy (ECOG 0–1; stable treated brain metastases allowed). Patients receive single-agent DRP-104 (sirpiglenastat) subcutaneously twice weekly in continuous 21-day cycles; DRP-104 is a tumor-targeted prodrug of DON, a broad glutamine antagonist that irreversibly inhibits multiple glutamine-utilizing enzymes.

ClinicalTrials.gov ID: NCT07249372

Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)

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 relapsed small cell lung cancer progressing after at least one prior platinum-based regimen (prior anti–PD-(L)1 allowed; ECOG 0–2; measurable disease; prior irinotecan allowed if not stopped for intolerance), this single-arm study evaluates irinotecan (days 1 and 8 every 21 days) combined with cirtuvivint (SM08502), an oral CDC2-like kinase (CLK) and DYRK inhibitor that modulates alternative pre-mRNA splicing (with downstream transcriptional effects including reduced Wnt-pathway gene expression). The trial dose-escalates to a recommended dose then expands to assess objective response rate, with PFS and OS as secondary outcomes.

ClinicalTrials.gov ID: NCT07155200