Clinical Trials for Small Cell Lung Cancer

A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (TIL or LN-145) in Patients With Metastatic 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.

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: This trial enrolls adults with metastatic, EGFR/ALK/ROS1-negative NSCLC who have progressed after prior immune checkpoint inhibitor and platinum chemotherapy, and who have a resectable tumor lesion and good performance status. Patients receive LN-145, an autologous tumor-infiltrating lymphocyte (TIL) therapy that reinfuses expanded tumor-reactive T cells following lymphodepleting chemotherapy, aiming to stimulate anti-tumor immunity.

ClinicalTrials.gov ID: NCT04614103

A Phase I Open-label, Multi-dose, Dose Escalation and Dose Expansion Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

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.

HealthScout AI summary: This trial enrolls adults with advanced NSCLC harboring EGFR mutations—including exon 20 insertions, classical (Ex19del, L858R), uncommon, or T790M drug-resistant mutations—to receive oral PLB1004, a novel irreversible EGFR tyrosine kinase inhibitor designed for broad activity across EGFR mutations with selectivity over wild-type EGFR.

ClinicalTrials.gov ID: NCT06046495

A Phase 1/2 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

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.

HealthScout AI summary: Maintenance trial for adults with ES-SCLC who have CR/PR/SD after 3–4 cycles of carboplatin/etoposide/atezolizumab (ECOG 0–1; treated, asymptomatic brain mets allowed), testing atezolizumab ± hyaluronidase every 21 days combined with quaratusugene ozeplasmid (Reqorsa), a non-viral lipid nanoparticle gene therapy delivering TUSC2 tumor suppressor to restore tumor suppression, disrupt oncogenic signaling, induce apoptosis, and enhance anti-tumor immunity. RP2D of quaratusugene ozeplasmid is 0.12 mg/kg IV every 21 days.

ClinicalTrials.gov ID: NCT05703971

Phase I Study of Valemetostat and Atezolizumab as Maintenance Therapy for Patients With Extensive-Stage Small Cell Lung Cancer

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.

HealthScout AI summary: Adults with newly diagnosed extensive-stage SCLC who have SD/PR/CR after 4 cycles of platinum doublet plus atezolizumab start maintenance atezolizumab (standard dosing) combined with oral valemetostat, an investigational dual EZH1/EZH2 inhibitor targeting H3K27me3 to suppress tumor proliferation. Key allowances include treated, controlled brain mets; key exclusions include recent consolidative chest RT, significant cardiac comorbidities/QTc prolongation, active infections, strong CYP3A modulators, and prior EZH inhibitor use.

ClinicalTrials.gov ID: NCT06807632

A Phase 1b/2, Multicenter, Open-label Platform Study of Select Immunotherapy Combinations in Adult Participants With Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) With High PD-L1 Expression

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.

HealthScout AI summary: This trial involves adult patients with untreated, advanced non-small cell lung cancer and high PD-L1 expression, evaluating cemiplimab combined with novel antibodies targeting TIM3, CD73, or NKG2A to assess safety, efficacy, and treatment outcomes.

ClinicalTrials.gov ID: NCT06162572

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

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.

HealthScout AI summary: This trial evaluates MDNA11, an IL-2 Superkine targeting the IL-2 beta receptor to enhance anti-tumor immunity, administered alone or with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors. Eligible patients must have an ECOG performance status of 0 or 1 and adequate organ function.

ClinicalTrials.gov ID: NCT05086692

A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-303, as Monotherapy and in Combination With Budigalimab (ABBV-181), in Adult 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.

HealthScout AI summary: This trial includes adult patients with relapsed or refractory advanced solid tumors, such as non-small cell lung cancer, renal cell carcinoma, and head and neck squamous cell carcinoma, who have an ECOG performance status of 0 or 1. It evaluates the safety and efficacy of ABBV-303, a trispecific killer cell engager targeting c-Met, as monotherapy and in combination with budigalimab, a PD-1 inhibitor.

ClinicalTrials.gov ID: NCT06158958

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other 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.

HealthScout AI summary: This trial involves patients with metastatic or unresectable non-small cell lung cancer and other solid tumors who receive BL-B01D1, a bispecific antibody-drug conjugate targeting EGFR and HER3, designed with a novel topoisomerase I inhibitor payload. The study evaluates different dosing schedules to determine safety, tolerability, and efficacy, particularly aiming to optimize dosing based on promising response rates in EGFR-mutated NSCLC and other cancer types.

ClinicalTrials.gov ID: NCT05983432

A Phase I Open-Label, Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Combination With Pembrolizumab in Patients With Immune Checkpoint Inhibitor Refractory 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.

HealthScout AI summary: The trial investigates the safety and tolerability of TILT-123, an oncolytic adenovirus encoding TNF-alpha and IL-2, in combination with Pembrolizumab, for adult patients with non-small cell lung cancer refractory to immune checkpoint inhibitors, aiming to stimulate anti-tumor immune responses and establish the Maximum Tolerated Dose.

ClinicalTrials.gov ID: NCT06125197

Phase I/II Study Exploring the Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

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.

HealthScout AI summary: This trial evaluates the combination of the investigational drug APL-101, a selective c-MET inhibitor, with standard osimertinib therapy in adults with EGFR-mutated metastatic NSCLC, focusing on those who have been on osimertinib for 8 to 16 weeks without disease progression. The study aims to establish the maximum tolerated dose and assess progression-free survival and objective response rate.

ClinicalTrials.gov ID: NCT04743505