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A PHASE II STUDY OF ABBV-399 (Process II) IN PATIENTS WITH C-MET POSITIVE STAGE IV OR RECURRENT SQUAMOUS CELL LUNG CANCER (LUNG-MAP SUB-STUDY)

Primary Objective The primary objective is to evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with ABBV-399 (Process II) in all patients with c-Met-positive lung squamous cell carcinoma. (SCCA) Secondary Objectives To evaluate investigator-assessed progression-free survival (IA-PFS) and overall survival (OS) with ABBV-399 (Process II) in immunotherapy-exposed and relapsed patients with c-Met positive squamous cell tumors. To evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with ABBV-399 (Process II) in immunotherapy-exposed and relapsed patients with c-Met positive squamous cell tumors. To evaluate IA-PFS, and OS in all patients with c-Met positive squamous cell tumors. To evaluate the duration of response (DoR) with ABBV-399 (Process II). To evaluate the frequency and severity of toxicities associated with ABBV-399 (Process II). Translational Medicine Objectives To identify additional predictive tumor/blood biomarkers that may correlate with response to ABBV-399 (Process II). To establish a tissue/blood repository from patients with refractory squamous cell carcinoma (SCCA) of the lung.

Primary Objective The primary objective is to evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with ABBV-399 (Process II) in all patients with c-Met-positive lung squamous cell carcinoma. (SCCA) Secondary Objectives To evaluate investigator-assessed progression-free survival (IA-PFS) and overall survival (OS) with ABBV-399 (Process II) in immunotherapy-exposed and relapsed patients with c-Met positive squamous cell tumors. To evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with ABBV-399 (Process II) in immunotherapy-exposed and relapsed patients with c-Met positive squamous cell tumors. To evaluate IA-PFS, and OS in all patients with c-Met positive squamous cell tumors. To evaluate the duration of response (DoR) with ABBV-399 (Process II). To evaluate the frequency and severity of toxicities associated with ABBV-399 (Process II). Translational Medicine Objectives To identify additional predictive tumor/blood biomarkers that may correlate with response to ABBV-399 (Process II). To establish a tissue/blood repository from patients with refractory squamous cell carcinoma (SCCA) of the lung.