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NCT07483983PHASE2RECRUITING

Study Investigating ASP3082 in Patients With Metastatic/Locally Advanced Non-small-cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response/Resistance

Phase 2, Multicenter, Open Label, Platform Study Investigating ASP3082 in Patients With Metastaic/Locally Non-Small-Cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response/Resistance

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris + Astellas Pharma Inc

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Metastatic/Locally Advanced Non-Small-Cell Lung Cancer, Metastatic/Locally Pancreatic Ductal Adenocarcinoma
Interventions
ASP3082
Enrollment
60 participants
Primary completion
Sep 2027
Study completion
Oct 2027
First posted
Mar 2026
Last updated
Mar 2026

Primary Endpoints (CT.gov)

Evaluate the best overall response (BOR) based on investigator assessment per RECIST v1.1

Time frame: Through treatment completion, median, 8 months

Secondary Endpoints

Duration of response (DOR)

Clinical benefit rate (CBR)

Progression-free survival (PFS)

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18 years 2. Patients with histologically confirmed diagnosis of locally advanced (unresectable) or metastatic NSCLC (cohort 1) or PDAC (cohort 2) and documented KRAS G12D mutation on the most recent tumor biopsy or circulating tumor DNA (ctDNA) analysis 3. For patients with NSCLC : 1. Patients with no known targetable genomic alterations, or an alteration for which no targeted therapy is approved (or accessible), must have been treated with at least 1 line of prior therapy, including a platinum-based regimen and a PD-(L) 1 blocker, combined or sequenced, and they must have experienced progression 2. Patients who have known actionable genomic alterations (EGFR, BRAF, and MET mutations or ALK, ROS1, RET, NTRK fusions) must have exhausted the available targeted therapy and have experienced disease progression after a platinum-based regimen 4. Patients with PDAC must have received only one prior line of chemotherapy for a minimum duration of 5 months and

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov

Related Program

Setidegrasib

Astellas Pharma Global Development, Inc.

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