Clinical Trials for Non-Small Cell Lung Cancer

LUNG-05: Investigating Chemotherapy Effectiveness for NSCLC Metastatic Patients

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

A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory/Recurrent Metastatic Solid Tumors

TrialFetch AI summary: Adults (ECOG 0–1) with refractory/recurrent locally advanced or metastatic solid tumors—particularly tissue factor–expressing cancers such as HNSCC, NSCLC, esophagogastric, colorectal, pancreatic ductal adenocarcinoma, cervical, endometrial, or urothelial carcinoma—after appropriate prior systemic therapy (prior-line limits vary by study part) are eligible. Treatment is STRO-004, a tissue factor–targeting antibody–drug conjugate delivering an exatecan (topoisomerase I inhibitor) payload, given as monotherapy with dose escalation/expansion or combined with pembrolizumab (PD-1 inhibitor).

ClinicalTrials.gov ID: NCT07227168

A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination With Budigalimab (ABBV-181) in Adult Subjects With Advanced Squamous Tumors

TrialFetch AI summary: Enrolling adults with advanced/metastatic squamous malignancies (including squamous NSCLC and head and neck SCC) that have progressed after or are not candidates for standard therapies, with measurable disease; prior PD-1/PD-L1 therapy is allowed and tumor tissue/biopsies are required for biomarker analyses in some cohorts. Patients receive oral ABBV-711 (mechanism/target not publicly disclosed) as monotherapy or in combination with budigalimab (ABBV-181), an engineered anti–PD-1 IgG1 monoclonal antibody.

ClinicalTrials.gov ID: NCT07241039

A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors

TrialFetch AI summary: Enrolls adults with relapsed/refractory locally advanced or metastatic solid tumors harboring a SMARCA4 loss-of-function mutation (ECOG 0–1, measurable disease) after progression on, intolerance of, or ineligibility for standard approved therapies. Patients receive oral once-daily PLX-61639, a SMARCA2 targeted protein degrader (synthetic-lethal strategy in SMARCA4-deficient tumors; DCAF16-linked, proteasome-mediated SMARCA2 degradation).

ClinicalTrials.gov ID: NCT07284186

An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors

TrialFetch AI summary: Enrolling adults (ECOG 0–1) with metastatic/unresectable solid tumors refractory to standard therapy (excluding melanoma, primary brain tumors/GBM, sarcoma, and pancreatic ductal adenocarcinoma; no active untreated brain mets), with expansion cohorts limited to ≤3 prior systemic lines and focused on PD-(L)1–naïve MSS colorectal cancer without liver metastases and PD-1 relapsed/refractory MSS endometrial cancer, RCC, or NSCLC. Patients receive IV ADU-1805 (anti-SIRPα mAb blocking the SIRPα–CD47 “don’t eat me” checkpoint to enhance myeloid/macrophage activity) every 3 weeks alone or with fixed-dose pembrolizumab every 3 weeks.

ClinicalTrials.gov ID: NCT05856981

A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

TrialFetch AI summary: Adults with locally advanced unresectable or metastatic solid tumors harboring a KRAS alteration (mutation or amplification) who have progressed on, are ineligible for, or declined standard-of-care therapy (Arm D additionally requires PD-L1 TPS ≥50%; excludes untreated CNS metastases and ILD/pneumonitis). Participants receive the first-in-human agent BMS-986523 (target/mechanism not publicly described) as monotherapy or combined with pembrolizumab (anti–PD-1), cetuximab (anti-EGFR), or gemcitabine plus nab-paclitaxel.

ClinicalTrials.gov ID: NCT07223047

A Phase 1, Open-label Dose Escalation and Expansion Study OF PT0511 in Participants With KRAS Mutated OR Amplified Advanced Solid Tumors

TrialFetch AI summary: Adults with locally advanced/metastatic measurable solid tumors harboring any KRAS mutation or wild-type KRAS amplification (ECOG 0–1) after 1–4 prior systemic regimens are treated with IV PT0511 monotherapy in dose-escalation/expansion cohorts; a colorectal cancer expansion cohort receives PT0511 plus cetuximab (anti-EGFR). PT0511 is an investigational KRAS-altered tumor–directed agent, but its specific molecular mechanism/allele selectivity is not publicly specified.

ClinicalTrials.gov ID: NCT07300150

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

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

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

A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer

TrialFetch AI summary: Adults with locally advanced or metastatic NSCLC (ECOG 0–1) with RECIST-measurable disease who have progressed on prior anti–PD-(L)1 therapy and have no remaining/acceptable standard metastatic options (treated stable brain metastases allowed) receive SAR445877 IV every 2 weeks. SAR445877 is a bifunctional fusion protein providing PD-1 blockade with targeted IL-15 pathway stimulation to expand/activate CD8+ T cells and NK cells, with mandatory repeat biopsies for biomarker studies.

ClinicalTrials.gov ID: NCT07133425