Clinical Trials for Small Cell Lung Cancer

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

Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant 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: Eligible patients are adults with locally advanced/metastatic KRAS G12V–mutant solid tumors (ECOG 0–1, measurable disease) that have progressed on or are intolerant to standard therapies. Treatment is oral RMC-5127, a KRAS G12V–selective RAS(ON) inhibitor (cyclophilin A–enabled tri-complex), given alone or combined with oral daraxonrasib (pan-RAS(ON) inhibitor) or with cetuximab.

ClinicalTrials.gov ID: NCT07349537

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Adults with previously untreated metastatic or unresectable stage IIIC/IV NSCLC (ECOG 0–2) eligible for first-line immune checkpoint inhibitor–based therapy, excluding tumors with actionable driver alterations (e.g., EGFR/ALK/ROS1/RET/NTRK/METex14/HER2). Patients are randomized to treatment selection guided by the PROphet Clinical Benefit blood-based proteomic assay plus CARG toxicity risk tool versus standard biomarker/clinical selection, choosing among standard PD-(L)1 antibody regimens with or without platinum chemotherapy and/or CTLA-4 blockade.

ClinicalTrials.gov ID: NCT07250477

Phase Ib/II Study of Safety and Efficacy of EZH2 Inhibitor, Tulmimetostat, and PD-1 Blockade for Treatment of 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: Enrolling adults with advanced, measurable NSCLC (ECOG 0–1) with RECIST-confirmed progression within 12 weeks on prior anti–PD-1/PD-L1–based therapy (first- or second-line), excluding EGFR/ALK-altered disease and patients with uncontrolled CNS metastases or significant autoimmune/pneumonitis history. Patients receive oral tulmimetostat (investigational dual EZH2/EZH1 inhibitor that reduces H3K27me3 to re-express silenced genes and potentially re-sensitize tumors to immunotherapy) with a 7-day run-in, combined with pembrolizumab 200 mg IV q3wk for up to 2 years.

ClinicalTrials.gov ID: NCT05467748

KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

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 nonsquamous NSCLC harboring KRAS G12C who have progressed after 1–2 prior lines including both PD-1/PD-L1 therapy and platinum chemotherapy, with no prior KRAS-targeted therapy and without active CNS disease or significant ILD/pneumonitis history. Patients are randomized to the investigational selective KRAS G12C-GDP covalent inhibitor MK-1084 combined with either patritumab deruxtecan (HER3-targeted topoisomerase I ADC), sacituzumab tirumotecan (TROP2-targeted topoisomerase I ADC), or cetuximab (EGFR monoclonal antibody).

ClinicalTrials.gov ID: NCT07286149

LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE)

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.

TrialFetch AI summary: This trial targets adult patients with non-small cell and small cell lung cancers experiencing oligo-progression while on stable systemic therapy, assessing the addition of locally ablative therapies like stereotactic ablative radiotherapy (SABR) and interventional radiology ablation for up to five or fewer metastatic lesions.

ClinicalTrials.gov ID: NCT06103682

SiCARIO (Split Course Adaptive Radioimmunotherapy) for the Treatment of Oligometastatic Non-Small Cell Lung Cancer (NSCLC) Using Biologically-Adaptive Radiotherapy - A Phase I/II Study

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.

TrialFetch AI summary: This trial involves adults with stage IVA/IVB or locally advanced NSCLC unsuitable for standard chemoradiation, using split-course adaptive radiation therapy combined with immunotherapy agents like pembrolizumab and ipilimumab, which enhance immune targeting of cancer cells, with or without standard chemotherapy like carboplatin.

ClinicalTrials.gov ID: NCT05501665