Phase Ib, multicenter, open label study of PDR001 in combination with platinum-doublet chemotherapy in PD-L1 unselected, metastatic NSCLC patients

Completed

• Conditions: lung cancer; non small cell lung cancer; 10038666; 10028971

• Registration Number: NL-OMON45593
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

* Female and male patients * 18 years.
* Stage IIIB or stage IV NSCLC or relapsed locally advanced or metastatic NSCLC. See protocol page 42 for more details, incl. criteria for groups A-D.
* Patient who received previous neo-adjuvant or adjuvant systemic therapy will be eligible for enrollment only if relapse has occurred more than 12 months from the end of this therapy.
* Histologically or cytologically confirmed diagnosis of NSCLC that is EGFR Wild-type, ALK-negative gene changes and ROS1-negative gene changes. See protocol page 42-43 for details.
* ECOG performance status 0-1.
* At least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1.

Exclusion Criteria

* History of severe hypersensitivity reactions to other monoclonal antibodies which in the opinion of the investigator may pose an increased risk of a serious infusion reaction.
* History of interstitial lung disease or interstitial pneumonitis. See protocol page 44 for details.
* Major surgery in the last 4 weeks. See protocol page 44 for details.
* Thoracic radiotherapy to lung fields in the last 4 weeks. More details on radiotherapy: see protocol page 44.
* Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months). See protocol page 44-45 for details.
* Active, known or suspected autoimmune disease or a documented history of autoimmune disease. See protocol page 45 for details.
* A condition requiring chronic systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within the last 7 days. See protocol page 45 for details.
* Any live vaccines against infectious diseases within the last 4 weeks.
* Pregnancy, lactation, insufficient contraception for females of childbearing potential and males.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Dose Limiting Toxicities (DLTs). ORR.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>PFS, Disease control rate (DCR), DOR (Duration of response) and TTR (Time to<br /><br>Response), OS. Adverse events. PK parameters, Antidrug-antibodies.</p><br>