Clinical Trials for Small Cell Lung Cancer

Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic 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: Adults with measurable advanced/metastatic solid tumors eligible for standard FDA-approved immune checkpoint inhibitor therapy (anti–PD-1/PD-L1 and/or anti–CTLA-4), including NSCLC, HNSCC, RCC, biliary, HCC, and melanoma, who are ICI-naive. Patients are randomized to receive their planned standard-of-care immunotherapy in the morning versus afternoon for the first 4 doses to evaluate whether administration timing affects outcomes.

ClinicalTrials.gov ID: NCT07405086

Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer

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 or recurrent ALK-rearranged NSCLC eligible for local consolidation therapy receive first-line lorlatinib, an oral third-generation ALK/ROS1 TKI with CNS activity, followed after induction by lorlatinib alone versus lorlatinib plus physician-selected local consolidation therapy such as radiation or other ablative approaches. Eligible patients include TKI-naïve or limited prior first-line ALK TKI exposure without progression; key exclusions include symptomatic CNS disease, significant uncontrolled cardiovascular disease, active IV-treated infection, and clinically relevant pneumonitis/ILD.

ClinicalTrials.gov ID: NCT07415005

Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC

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 relapsed extensive-stage SCLC after one prior platinum/etoposide-based line are enrolled, including ECOG 0-2 patients with measurable disease and treated/asymptomatic brain metastases allowed. Biomarker-positive patients are randomized to oral stenoparib, an investigational PARP inhibitor targeting DNA damage repair, plus oral temozolomide versus IV lurbinectedin; biomarker-negative patients receive lurbinectedin.

ClinicalTrials.gov ID: NCT06681220

Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial (ACTION-Brain Metastases: Pilot Pragmatic Trial)

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 solid tumors and untreated brain metastases ≤3 cm receive physician-selected CNS-active standard-of-care therapy, including immune checkpoint inhibitors, EGFR/ALK/BRAF-MEK inhibitors, HER2-directed antibody-drug conjugates, endocrine therapy, or chemotherapy. Brain radiation is deferred with MRI surveillance in patients achieving intracranial stability or response and reserved for progression.

ClinicalTrials.gov ID: NCT06974370

A Randomized Phase II Study of Radiotherapy Plus Immune Checkpoint Inhibitor Therapy Versus Standard of Care Chemotherapy in Patients With Metastatic or Relapsed Non-Small Cell Lung Cancer Previously Treated With Immunotherapy

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 metastatic or recurrent, measurable NSCLC progressing after exactly one prior anti–PD-1/PD-L1 line, ECOG 0–2, and an ablative-radiotherapy–eligible lesion are randomized to hypofractionated ablative radiotherapy plus investigator-selected PD-1, PD-L1, and/or CTLA-4 checkpoint blockade versus standard chemotherapy such as docetaxel ± ramucirumab or gemcitabine. Sensitizing EGFR, ALK, ROS1, RET, NTRK, or HER2 alterations are excluded.

ClinicalTrials.gov ID: NCT07603856

A Phase Ib/II, Single-Center, Open-Label Study of First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (FLINN)

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 untreated stage IV or recurrent metastatic NSCLC, ECOG 0–1, and no major actionable driver alterations receive first-line nivolumab (PD-1 inhibitor) plus ipilimumab (CTLA-4 inhibitor) and subcutaneous nogapendekin alfa inbakicept (N-803), an IL-15 superagonist that activates NK and CD8+ T cells. Treated, neurologically stable brain metastases are permitted.

ClinicalTrials.gov ID: NCT07355205

Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

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 EGFR-mutated NSCLC that transformed to small cell lung cancer after osimertinib receive IV lurbinectedin, a DNA minor-groove binder that disrupts oncogenic transcription and induces DNA damage, plus oral osimertinib, a CNS-active third-generation EGFR inhibitor. Prior platinum/etoposide after transformation is permitted.

ClinicalTrials.gov ID: NCT07153055

A Phase 2, Multicenter, Open-Label, Single-Arm Study of Lurbinectedin in Combination With Durvalumab as First-line Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer Following Induction Treatment With Platinum Based Chemotherapy and Durvalumab

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 extensive-stage small-cell lung cancer, ECOG 0–1, no history of CNS metastases, and no progression after platinum-etoposide plus durvalumab induction receive first-line maintenance lurbinectedin plus durvalumab. Lurbinectedin binds the DNA minor groove to disrupt transcription and induce DNA damage; durvalumab blocks PD-L1.

ClinicalTrials.gov ID: NCT07459634

A Phase I Clinical Trial of Carfilzomib in Combination With Sotorasib in Patients With KRASG12C Mutated Advanced Non-Small Cell Lung Cancer

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: This trial evaluates the combination of carfilzomib, a proteasome inhibitor, and sotorasib, a KRAS G12C inhibitor, in adults with advanced or metastatic KRAS G12C-mutated non-small cell lung cancer who have progressed after previous KRAS inhibitor treatments.

ClinicalTrials.gov ID: NCT06249282

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.

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: 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