A RANDOMIZED, MULTICENTER, PHASE IB/III STUDY TO INVESTIGATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF ATEZOLIZUMAB SUBCUTANEOUS COMPARED WITH ATEZOLIZUMAB INTRAVENOUS IN PATIENTS WITH PREVIOUSLY TREATED LOCALLY ADVANCED OR METASTATIC NONSMALL CELL LUNG CANCER

Not Applicable

• Conditions: -C34 Malignant neoplasm of bronchus and lung; Malignant neoplasm of bronchus and lung; C34

• Registration Number: PER-097-20
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study Completion: 2022-02-10
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Signed Informed Consent Form
-Age >=18 years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator´s judgment
- Measurable disease as defined by RECIST v1.1 Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease.
-Eastern Cooperative Oncology Group Performance Status of 0 or 1.
For more details, review the protocol.

Exclusion Criteria

-Symptomatic, untreated, or actively progressing CNS metastases
- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for
-2 weeks prior to enrollment
-History of leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Patients with indwelling catheters (e.g., PleurX) are allowed.
For more details, review the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified