Clinical Trials for Small Cell Lung Cancer

IIT2022-05-Sankar-BELIEVE: Phase II Study of Bevacizumab in Combination With Chemoimmunotherapy and Maintenance Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver 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.

TrialFetch AI summary: Adults with treatment-naïve extensive-stage small cell lung cancer and radiographic liver metastases receive carboplatin/etoposide plus atezolizumab (anti–PD-L1) and bevacizumab (anti–VEGF) for 4 cycles, followed by maintenance atezolizumab/bevacizumab. Includes ECOG 0–2, measurable disease, and allows selected stable/asymptomatic brain metastases; excludes significant bleeding/thromboembolic risk, uncontrolled hypertension, recent major surgery, active autoimmune disease requiring therapy, and active HBV.

ClinicalTrials.gov ID: NCT05588388

Prevention of Datopotamab Deruxtecan (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087)

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: Adults with advanced/metastatic HER2-negative breast cancer (TNBC or HR+/HER2− post-CDK4/6 and chemo/ADC) or previously treated non-squamous NSCLC receive datopotamab deruxtecan (TROP2-directed ADC delivering a topoisomerase I inhibitor) plus prophylactic dexamethasone mouthwash. The study assesses whether short-course steroid mouthwash during the first three cycles reduces Dato-DXd–associated stomatitis while patients continue Dato-DXd q3w.

ClinicalTrials.gov ID: NCT06974604

An Open-Label Phase 1 Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of PRTH-101 Alone or in Combination With Pembrolizumab in Adults With Advanced or Metastatic 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.

TrialFetch AI summary: Adults with unresectable advanced/metastatic solid tumors (excluding HCC, sarcomas, gliomas) who have progressed on or are unsuitable for standard therapy receive PRTH-101, an anti‑DDR1 monoclonal antibody intended to disrupt collagen-mediated T‑cell exclusion, either as monotherapy or combined with pembrolizumab. Suitable for ECOG 0–1 with treated/stable CNS disease only; key exclusions include active autoimmune disease on immunosuppression, uncontrolled infections, and recent systemic therapy or radiation.

ClinicalTrials.gov ID: NCT05753722

DISCERN: Dual Immune Strategy Versus Single Checkpoint Inhibition Efficacy Response in PDL-1 Negative Non-Small Cell Lung Cancer (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.

TrialFetch AI summary: Adults with stage IV, PD-L1–negative NSCLC without actionable drivers and detectable baseline ctDNA are randomized to standard chemo plus pembrolizumab versus chemo plus dual checkpoint blockade (nivolumab [PD-1] + ipilimumab [CTLA-4]), with maintenance per histology. Aims to assess early molecular response (ctDNA clearance by Cycle 4 Day 1) and key clinical outcomes; treated/stable CNS metastases allowed.

ClinicalTrials.gov ID: NCT06364917

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)

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: Untreated adults with locally advanced unresectable or metastatic non-squamous NSCLC that overexpresses HER2 and has PD-L1 TPS &lt;50%, without actionable driver alterations or HER2 mutation. Randomized to trastuzumab deruxtecan (HER2-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor) plus pembrolizumab versus standard pemetrexed/platinum plus pembrolizumab.

ClinicalTrials.gov ID: NCT06899126

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)

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: Adults with locally advanced or metastatic solid tumors eligible for on-label PD-1 therapy (nivolumab or pembrolizumab) are randomized in a crossover design to receive standard PD-1 inhibitors via subcutaneous versus intravenous administration, assessing patient/clinician preference, satisfaction, QoL, safety, and selected clinical outcomes. Includes PD-(L)1–naïve patients or those willing to switch; excludes prior severe hypersensitivity and transplant history.

ClinicalTrials.gov ID: NCT07223424

LUNG-05: Investigating Chemotherapy Effectiveness for NSCLC Metastatic Patients

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: Adults with previously treated stage IV NSCLC (ECOG 0–2) eligible for standard cytotoxic chemotherapy receive NCCN-concordant agents (e.g., docetaxel, paclitaxel, gemcitabine, pemetrexed, vinorelbine) selected by the investigational OncoChoice ex vivo drug-responsiveness assay performed on fresh tumor/fluid samples. Single-arm study assessing objective response, with secondary endpoints including 6-month PFS, OS, and QoL.

ClinicalTrials.gov ID: NCT06576635

Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types

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: Enrolling adults (ECOG 0–2) with newly diagnosed extensive-stage small cell lung cancer on standard platinum/etoposide plus PD-L1 inhibitor chemoimmunotherapy (≤3 cycles at enrollment, no prior thoracic RT) to receive response-adaptive ultrahypofractionated thoracic stereotactic RT (PULSAR) in up to three 7–10 Gy “pulses” timed around infusion days, with pulses omitted if complete response occurs. Also enrolling adults with 1–5 MRI-defined brain metastases (2–5 cm; brainstem 1.5–5 cm; no prior WBRT or prior focal therapy to target lesions) for two-pulse fractionated SRS/FSRT where a 4-week response MRI can de-escalate treatment by omitting pulse 2 if ≥25% volume reduction.

ClinicalTrials.gov ID: NCT07139990

PRISM: Phase 1b of Retifanlimab and Ruxolitinib In Solid Malignancies Progressing on Prior Checkpoint Inhibition

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: Adults with advanced/metastatic clear cell renal cell carcinoma or non-small cell lung cancer who had at least stable disease on one prior line of PD-1/PD-L1 therapy but then radiographically progressed within 6 months of stopping it (ECOG 0–1; measurable disease; no active CNS disease or uncontrolled autoimmune disease) and lack/decline standard options. Patients receive retifanlimab (anti–PD-1 antibody) 500 mg IV every 4 weeks as checkpoint rechallenge combined with oral ruxolitinib (JAK1/2 inhibitor) twice daily with dose escalation to define the recommended dose.

ClinicalTrials.gov ID: NCT07219576

PRIME-LRT: PRomoting IMmunotherapy Efficacy With Low-Dose Liver RT

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: Enrolls adults with biopsy-proven NSCLC (excluding EGFR/ALK/ROS1/RET-altered tumors) or melanoma with radiographic liver metastases, ECOG 0–2, eligible for standard PD-1/PD-L1 checkpoint inhibitor–based therapy (± chemotherapy and/or CTLA-4 inhibition per routine practice). All patients receive standard systemic therapy plus investigational low-dose liver radiation delivered in the week before cycles 1, 2, and 3 to potentially modulate the hepatic immune microenvironment and enhance checkpoint inhibitor efficacy.

ClinicalTrials.gov ID: NCT07225036