Clinical Trials for Small Cell Lung Cancer

A Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

No known activity

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

HealthScout AI summary: Enrolling adults with progressive, unresectable/metastatic, SSTR2-positive NETs (primarily GEP-NETs; also bronchial NETs and pheo/para) who are PRRT-naïve and ECOG 0–2. Investigational therapy is [212Pb]VMT-α-NET, an SSTR2-targeted alpha-emitting radiopharmaceutical (212Pb/212Bi/212Po) given up to four cycles every ~8 weeks with amino acid renal protection; early cohorts include a 203Pb imaging microdose for dosimetry.

ClinicalTrials.gov ID: NCT05636618

A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination With Carboplatin, Etoposide, and Atezolizumab in Induction and With Atezolizumab in Maintenance Phase

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.

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.

HealthScout AI summary: Adults with newly diagnosed extensive-stage SCLC who are SSTR-positive on 68Ga-DOTA-TATE PET receive first-line carboplatin/etoposide/atezolizumab with or without [177Lu]Lu-DOTA-TATE, a somatostatin receptor–targeted radioligand delivering beta radiation. Maintenance is with atezolizumab ± [177Lu]Lu-DOTA-TATE; excludes prior ICI therapy and active autoimmune disease.

ClinicalTrials.gov ID: NCT05142696

Phase 1 Trial With GD2-SADA:177Lu-DOTA Drug Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma

No known activity

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

HealthScout AI summary: Enrolling adults (≥18; ≥16 for high-risk neuroblastoma or sarcoma) with measurable, GD2-positive recurrent/metastatic solid tumors (e.g., SCLC, high-risk neuroblastoma, sarcomas, melanoma) with ECOG 0–1 and adequate organ function. Two-step pretargeted radioimmunotherapy: IV GD2-SADA bispecific fusion protein (targets GD2; self-assembling/disassembling to enhance tumor avidity and renal clearance) followed after a set interval by 177Lu-DOTA to deliver beta radiation to tumor-retained antibody; dose-escalation with repeat cycles allowed.

ClinicalTrials.gov ID: NCT05130255

An Open-Label, Multicenter, Phase 1/1b Study of RNDO-564 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer and Other Solid Tumors Associated With Nectin-4 Expression

No known activity

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

HealthScout AI summary: Adults with incurable, locally advanced/metastatic Nectin-4–positive solid tumors—emphasizing relapsed/refractory urothelial cancer—receive RNDO-564 weekly as monotherapy or combined with pembrolizumab every 3 weeks. RNDO-564 is a fully human CD28 × Nectin-4 costimulatory bispecific antibody intended to deliver localized CD28 T‑cell costimulation at Nectin-4–expressing tumors; early cohorts include multiple Nectin-4–associated cancers, with randomized dose-optimization in urothelial cancer.

ClinicalTrials.gov ID: NCT07218003

A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors

No known activity

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

HealthScout AI summary: Adults with advanced/metastatic solid tumors lacking effective standard options (broad basket with prioritized cohorts such as CRC, SCLC, HNSCC, NSCLC, pancreatic, and bladder; some genomically enriched) receive oral single‑agent CP-383 in dose escalation and tumor‑specific expansions. CP-383 is a first‑in‑class small molecule designed to modulate lipid‑binding pockets on oncogenic proteins (exact target undisclosed).

ClinicalTrials.gov ID: NCT07030257

A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.

No known activity

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

HealthScout AI summary: Adults with advanced/metastatic urothelial/bladder cancer, NSCLC, HNSCC, esophageal cancer, or pancreatic adenocarcinoma (ECOG 0–1) receive PF-08046876, an ITGB6-targeted antibody–drug conjugate delivering a topoisomerase I payload, as IV monotherapy after prior standard therapy (≤2 prior lines in Part 2). Dose escalation/optimization and tumor-specific expansions assess safety, PK, and preliminary activity; excludes prior camptothecin/topo I ADC exposure and significant GI or pulmonary comorbidities.

ClinicalTrials.gov ID: NCT07090499

A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors

No known activity

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

HealthScout AI summary: Adults with advanced, refractory solid tumors (ECOG 0–1) receive an allogeneic, off‑the‑shelf iPSC‑derived CAR T product (FT836) targeting stress‑inducible MICA/MICB (engineered to reduce antigen shedding) as monotherapy or combined with trastuzumab (HER2), cetuximab (EGFR), and/or paclitaxel. Multi‑arm cohorts assess safety and preliminary activity to establish RP2D for the combination regimens.

ClinicalTrials.gov ID: NCT07216105

A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

No known activity

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

HealthScout AI summary: Adults with advanced/metastatic NSCLC, SCLC, endometrial cancer, or triple‑negative breast cancer after standard options receive LY4175408, an investigational PTK7‑targeted antibody–drug conjugate delivering an exatecan (topoisomerase I inhibitor) payload, given IV every 21 days. Requires ECOG 0–1 and measurable disease (for later cohorts); excludes prior PTK7 topoisomerase I ADCs, uncontrolled CNS metastases, significant cardiac disease, ILD/pneumonitis, active infection, and prolonged QTc.

ClinicalTrials.gov ID: NCT07046923

A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors

No known activity

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

HealthScout AI summary: Adults with advanced solid tumors including HNSCC, pancreatic adenocarcinoma, NSCLC, HR+/HER2− breast cancer post‑CDK4/6 inhibitor, or platinum‑resistant high‑grade serous ovarian/related cancers receive the oral CDK7 inhibitor GTAEXS617 (transcription/cell‑cycle regulator) as monotherapy or combined with standard-of-care regimens. Eligible patients have ECOG 0–1 and adequate organ function; study explores safety, PK, and preliminary activity with tumor biopsies required.

ClinicalTrials.gov ID: NCT05985655

A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

No known activity

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

HealthScout AI summary: Monotherapy ALE.P03, a Claudin‑1–targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor payload, for adults with centrally confirmed CLDN1-positive advanced/metastatic solid tumors limited to mCRC, intrahepatic cholangiocarcinoma, squamous NSCLC, urothelial carcinoma, or cervical squamous cell carcinoma. Requires RECIST-measurable, ECOG 0–1 disease with prior standard therapy (dose escalation: refractory/intolerant to all; expansion/phase II: 1–2 prior lines and prior targeted therapy if actionable drivers), excluding active CNS metastases and significant ILD/pneumonitis.

ClinicalTrials.gov ID: NCT07169734