Clinical trial · Interventional
A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]
A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression. Eligible participants will be categorized in to three groups as follows: 1. Participants with no prior chemotherapy for advanced disease; 2. Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants); 3. Participants who are 2L+ and previously treated for brain metastases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Atezolizumab (MPDL3280): 1L Participants
- description
- Participants with no prior chemotherapy for advanced NSCLC disease will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
- interventionNames
- Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
- type
- EXPERIMENTAL
- label
- Atezolizumab (MPDL3280): 2L+ Participants
- description
- Participants who progress during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
- interventionNames
- Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC * PDL1-positive status as determined by an immunohistochemistry assay performed by a central laboratory. A positive result in chemotherapy, chemoradiation of the tumor sample biopsy will satisfy the eligibility criterion * Eastern Cooperative Oncology group Performance Status of 0 or 1 * Life expectancy greater than or equal to 12 weeks * Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 * Adequate hematologic and end organ function Exclusion Criteria: * Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed. Hormone-replacement therapy or oral contraceptives, and tyrosine kinase inhibitors approved for treatment of NSCLC discontinued greater than 7 days prior to Cycle 1 Day 1 * Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment * Known central nervous system disease, including treated brain metastases in the following participants: 1. who will not receive prior chemotherapy for advanced disease 2. who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (referred as 2L+ participants) * Participants with a history of treated asymptomatic brain metastases are allowed in the 2L+ participants and previously treated for brain metastases. * Leptomeningeal disease * Uncontrolled tumor-related pain * Uncontrolled hypercalcemia
References
Publications (1)
- DERIVEDShemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685. PMID 33241650