Clinical Trials for Small Cell Lung Cancer

A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult With Advanced Non-Small Cell Lung Cancer: The ACHIEVE 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.

HealthScout AI summary: This trial enrolls patients aged 70 or older with stage IIIB-IV NSCLC, ECOG 2, and PD-L1 TPS 1-49% (without actionable mutations or chemo-radiation candidacy) to compare pembrolizumab (anti-PD-1 immunotherapy) plus platinum-based chemotherapy versus pembrolizumab alone. Both arms include pembrolizumab maintenance, with the primary outcome of overall survival.

ClinicalTrials.gov ID: NCT06096844

LUNG-IST-127: a Pilot Phase II Study of Maintenance Cabozantinib Plus Pembrolizumab (CP) for Patients with Metastatic SqNSCLC with Disease Control Following Induction Therapy

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: Eligible patients are adults with metastatic squamous NSCLC (stage IV, ECOG 0-2) who achieved disease control after four cycles of first-line pembrolizumab, carboplatin, and (nab-)paclitaxel; these patients receive maintenance cabozantinib (a multi-kinase inhibitor targeting MET/VEGFR and others) plus pembrolizumab.

ClinicalTrials.gov ID: NCT05613413

A Randomized Phase II Study of Tepotinib With or Without Ramucirumab in Participants With MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-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.

HealthScout AI summary: This trial enrolls adults with advanced or recurrent non-small cell lung cancer harboring MET exon 14 skipping mutations who have progressed after at least one prior systemic therapy, testing tepotinib (oral MET tyrosine kinase inhibitor) with or without ramucirumab (IV VEGFR2 inhibitor). Patients must not have prior exposure to MET or angiogenesis inhibitors and must lack other actionable mutations.

ClinicalTrials.gov ID: NCT06031688

A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)

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 previously untreated advanced or metastatic non-squamous NSCLC with HER2 overexpression (no EGFR/ALK alterations), testing trastuzumab deruxtecan (HER2-directed antibody-drug conjugate) in combination with investigational bispecific checkpoint inhibitors (volrustomig [PD-1/CTLA-4] or rilvegostomig [PD-1/TIGIT]), with or without platinum chemotherapy. Patients must have good performance status and no major comorbidities.

ClinicalTrials.gov ID: NCT04686305

Phase II Trial of Lung Chemoemobolization

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 unresectable, unablatable non-small cell lung cancer or lung metastases progressing on or intolerant to systemic therapy receive transarterial chemoembolization (TACE) with intra-arterial mitomycin (alkylating cytotoxic agent), lipiodol (contrast/drug carrier), and embospheres (arterial embolic microspheres). This trial targets patients not eligible for surgery, ablation, or radiation, assessing local disease control using a locoregional approach.

ClinicalTrials.gov ID: NCT05672108

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

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: Eligible patients have locally advanced or metastatic solid tumors with HER2 expression—including NSCLC, breast (both HER2+ and HER2-), urothelial, gastric, esophageal, or other Erbb2-amplified cancers—who have progressed on or are intolerant to standard treatments. Patients receive DF1001, a tri-specific NK cell engager targeting HER2 and activating NK and T cells, as monotherapy or in combination with nivolumab, nab-paclitaxel, or sacituzumab govitecan-hziy.

ClinicalTrials.gov ID: NCT04143711

A Multicenter Phase II Randomized Trial Of Immunotherapy Versus Chemotherapy Guided By Circulating Tumor DNA-Based Molecular Response On Patients With Metastatic NSCLC

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 previously untreated, stage IV NSCLC, positive PD-L1 (≥1%), detectable ctDNA, and no actionable driver mutations, to compare nivolumab plus ipilimumab (immune checkpoint inhibitors) with or without addition of platinum-doublet chemotherapy based on early ctDNA response. Treatment is adapted according to ctDNA response after initial immunotherapy.

ClinicalTrials.gov ID: NCT05715229

A Pilot Study of Spatially Fractionated Radiation Therapy in Patients with Extra-Cranial Soft Tissue Metastases

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 or metastatic solid tumors and at least two extracranial soft tissue metastases (one ≥4 cm) requiring palliative radiation, comparing lattice radiation therapy (LRT)—a spatially fractionated radiotherapy technique that may enhance immune effects—to standard SBRT, with each patient receiving both treatments at different sites.

ClinicalTrials.gov ID: NCT05837767

A Phase 1/1b Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Participants with BRAF And/or NRAS Mutation-positive 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.

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 advanced or metastatic solid tumors with BRAF Class I, II, or III mutations, or NRAS-mutant melanoma, to receive KIN-2787 (exarafenib)—a novel pan-RAF inhibitor—either as monotherapy or in combination with the MEK inhibitor binimetinib. Prior BRAF-, MEK-, or MAPK-directed therapies are excluded in the dose expansion phase.

ClinicalTrials.gov ID: NCT04913285

Beamion LUNG-1: An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of Zongertinib (BI 1810631) as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations

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 advanced or metastatic solid tumors harboring HER2 aberrations, with a focus on NSCLC patients with HER2 mutations, including those previously treated, treatment-naïve, or with brain metastases. Patients receive zongertinib, an oral, selective covalent tyrosine kinase inhibitor targeting both wild-type and mutant HER2 while sparing EGFR.

ClinicalTrials.gov ID: NCT04886804