Clinical Trials for Small Cell Lung Cancer

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

A Phase 1a/1b Trial in Relapsed/Refractory Small Cell Lung Cancer to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg/mL) for Intravenous Infusion

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 relapsed/refractory, incurable small cell lung cancer with ≥1 RECIST-measurable lesion and ECOG 0–1 (controlled, asymptomatic CNS metastases allowed if stable), excluding mixed SCLC/NSCLC histology and significant cardiac/QTc or retinal/ophthalmologic disease. Patients receive ST-001 (IV nanoparticle fenretinide, a synthetic retinoid that modulates sphingolipid metabolism via DES1/DEGS1 inhibition to increase dihydroceramides) as a 4-hour infusion daily for 5 consecutive days every 3 weeks in dose-escalation/expansion to define MTD and assess preliminary activity.

ClinicalTrials.gov ID: NCT06922539

Iadademstat and Radiation Therapy With Atezolizumab in Extensive Stage Small-cell Lung Cancer (ES-SCLC) Patients With Persistent, Recurrent or Progressive Disease After First Line Systemic Therapy

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 small-cell lung cancer with persistent/recurrent/progressive disease after first-line platinum-based therapy (including those initially treated as limited-stage who later recur with extensive disease), ECOG 0–2, RECIST-measurable disease, and at least one lesion suitable for SBRT plus a separate lesion amenable to mandatory pre- and post-SBRT biopsies; prior immune checkpoint inhibitor exposure is allowed and selected treated/asymptomatic brain metastases are permitted. Treatment is oral iadademstat (ORY-1001; covalent LSD1/KDM1A epigenetic inhibitor) combined with atezolizumab (PD-L1 antibody, 1680 mg IV q28d) and SBRT to a selected lesion, followed by maintenance iadademstat plus atezolizumab until toxicity or loss of benefit.

ClinicalTrials.gov ID: NCT07113691

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted 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 centrally confirmed MTAP homozygous loss/deletion and advanced solid tumors (ECOG 0–1) who have progressed after standard therapy are enrolled in dose escalation (mesothelioma, gastroesophageal, NSCLC, urothelial), with dose-expansion limited to MTAP-deleted NSCLC after platinum chemotherapy and PD-1/PD-L1 therapy (≤3 prior lines, prior appropriate targeted therapy if actionable). Participants receive IDE892, an MTA-cooperative PRMT5 inhibitor, as monotherapy or combined with IDE397, an oral MAT2A inhibitor, in 21-day cycles.

ClinicalTrials.gov ID: NCT07277413

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With 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 locally advanced/metastatic solid tumors harboring KRAS/NRAS/HRAS mutations (ECOG 0–1, measurable disease) who have progressed on/intolerant to standard therapy are eligible for dose exploration, with expansions in previously untreated non-squamous NSCLC without another actionable driver and in solid tumors/CRC with ≤2 prior advanced lines (HNSCC excluded). Patients receive an oral RAS(ON) inhibitor—daraxonrasib (pan-RAS(ON)), elironrasib (KRAS G12C(ON)), or zoldonrasib (KRAS G12D(ON))—combined with ivonescimab (PD-1/VEGF bispecific antibody), with select cohorts adding platinum/pemetrexed chemotherapy, cetuximab, or additional RAS(ON) inhibitor.

ClinicalTrials.gov ID: NCT07397338