A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)

• Status: Not yet recruiting
• Trial end date: 2026-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to characterize the safety and tolerability of MORAb-202, and to assess the objective response rate in participants with previously treated, metastatic NSCLC AC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Farletuzumab

Criteria

Inclusion Criteria:

• Histologically or cytologically documented metastatic NSCLC AC (as defined by the 8th International Association for the Study of Lung Cancer Classification).

• Participants without genetic alterations or unknown genetic alterations in the metastatic setting after receiving:

i) 1 prior line of therapy if platinum-doublet chemotherapy and anti-PD-1/PD-L1 were given concurrently or ii) 2 prior lines of therapy if platinum-doublet chemotherapy and anti-PD-1/PD-L1 were given sequentially.

• Participants with known targetable genetic alterations in the metastatic setting after receiving:

i) At least 1 approved targeted therapy and ii) No more than 3 prior lines of systemic therapy (including no more than 1 line of chemotherapy).

• Either FFPE tissue block (preferred), newly cut unstained slides or newly obtained biopsies must be available for assessment by IHC at a central laboratory prior to randomization.

Exclusion Criteria:

• NSCLC histologies other than AC (ie, squamous cell carcinoma, large cell carcinoma).

• Pulmonary function test (PFT) abnormalities: Forced expiratory volume during first second of forced breath (FEV1) < 70%, or forced vital capacity (FVC) < 60%, and diffusing capacity of the lung for carbon monoxide (DLCO) < 80%.

• Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage.

• Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed > 12 months before treatment.

• Recent chest radiotherapy. Participants with chest or chest wall radiation may be permitted if chest radiation is documented > 6 months before starting study treatment.

Other protocol-defined inclusion/exclusion criteria apply.