CompletedPhase 2

A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)

United States181 participantsStarted 2017-04-20

Plain-language summary

This study was designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant therapy consisted of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy consisted of up to 12 months of atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy. All participants who undergo surgery entered a surveillance period, which consisted of standardized blood sample collection and Chest CT Scans, for up to 2 years. All participants were monitored for disease recurrence and survival for up to 3 years after last dose of study drug.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Pathologically documented Stage IB, II, IIIA, or selected IIIB, including T3N2 or T4 (by size criteria, not by mediastinal invasion) NSCLC * Adequate pulmonary and cardiac function * Available biopsy of primary tumor with adequate samples * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease * Any prior therapy for lung cancer within 3 years. * Prior treatment with anti-PD-1 or PD-L1 therapies * History or risk of autoimmune disease

What they're measuring

Percentage of Participants With Major Pathologic Response (MPR)

Timeframe: After surgery (approximately 10 weeks)

Trial details

NCT IDNCT02927301

SponsorGenentech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-05-07

Results submitted2021-04-23