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Completed

NCT Number: NCT03456063

A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)

This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.

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Key information

Conditions

Non-Small-Cell Lung

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St George Hospital, Kogarah, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Histologically or cytologically confirmed, resectable Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the AJCC/UICC staging system
  • Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
  • Adequate pulmonary and cardiac function to undergo surgical resection
  • Measurable disease as defined by RECIST v1.1
  • Adequate hematologic and end organ function
  • Negative HIV test at screening
  • Negative for active HBV and HCV at screening
  • Adequate tissue for PD-L1 IHC assessment

Exclusion criteria

  • NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma
  • Mixed NSCLC and small cell lung cancer histology
  • Any prior therapy for lung cancer
  • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated expected curative outcome
  • Non-squamous NSCLC histology with activating ALK and EGFR mutation
  • Pregnant or lactating women
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active of active pneumonitis on screening chest Computed Tomography (CT) scan
  • Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
  • Severe infection within 4 weeks prior to randomization
  • Significant history of cardiovascular disease

Treatment and study plan

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Drug

Atezolizumab will be administered as intravenous (IV) infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle (every 3 weeks) for 4 cycles during the neoadjuvant treatment phase

Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) every 3 weeks for 16 cycles during the post-operative adjuvant phase

Other names: Tecentriq

placebo comparator

Drug

Placebo will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase

Nab-paclitaxel

Drug

Nab-paclitaxel 100 mg/m^2 will be administered intravenously on Days 1, 8, and 15 of each 21 day cycle for 4 cycles during the neoadjuvant treatment phase

Other names: Abraxane

Pemetrexed

Drug

Pemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase

Other names: Alimta

carboplatin

Drug

Carboplatin initial target AUC of 6 mg/mL/min will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase

Cisplatin

Drug

Cisplatin 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase

Gemcitabine

Drug

Gemcitabine 1250 mg/m^2 will be administered intravenously on Day 1 and 8 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase

Other names: Gemzar

Primary outcomes

  1. Independent Review Facility (IRF)-Assessed Event Free Survival (EFS)

    Time frame: Up to approximately 96 months

    IRF-assessed EFS is defined as the time from randomization to the first documented disease progression per RECIST v1.1 that precludes surgery, local or distant disease recurrence, or death from any cause, whichever occurs first.

Secondary outcomes

  1. Pathological Complete Response (pCR)

    Time frame: At time of surgery

    pCR is defined as the absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes as assessed by central and local pathology laboratory.

  2. Major Pathological Response (MPR)

    Time frame: At time of surgery

    MPR is defined as ≤ 10% residual viable tumor cells at the time of surgical resection in the primary tumor, as assessed by central and local pathology laboratory.

  3. Objective Response (OR)

    Time frame: Prior to surgery, up to approximately 84 days

    Objective response is defined as a complete response or partial response, as determined by the investigator according to RECIST v1.1

  4. Overall Survival (OS)

    Time frame: Up to approximately 96 months

    OS is defined as the time from randomization to death from any cause during the course of the study.

  5. Investigator-Assessed EFS

    Time frame: Up to approximately 96 months

    EFS is defined as the time from randomization to the first documented disease progression per RECIST v1.1 that precludes surgery, local or distant disease recurrence, as assessed by the investigator; or death from any cause, whichever occurs first.

  6. Disease-Free Survival (DFS)

    Time frame: Up to approximately 96 months

    DFS is defined as the time from the first date of no disease to local or distant recurrence (including occurrence of new primary NSCLC) or death due to any cause, whichever occurs first, as determined by the investigator during the adjuvant treatment and observation follow-up

  7. 2-Year and 3-Year OS

    Time frame: Up to approximately 96 months

    The 2-year and 3-year OS rate is defined as the probability that a participant will be alive 2 years and 3 years after randomization, respectively.

  8. 2-Year and 3-Year Independent Review Facility-Assessed EFS

    Time frame: Up to approximately 96 months

    EFS is defined as the probability that a participant will be event-free 2 years and 3 years after randomization, respectively, as assessed by the Independent Review Facility.

  9. 2-Year and 3-Year Investigator-Assessed EFS

    Time frame: Up to approximately 96 months

    EFS is defined as the probability that a participant will be event-free 2 years and 3 years after randomization, respectively, as assessed by the Investigator.

  10. Change from baseline in HRQoL scores

    Time frame: Up to approximately 96 months

    Change from baseline in HRQoL scores as assessed through use of the two-item GHS/HRQoL subscale (Questions 29 and 30) of the EORTC QLQ-C30 at each assessment time point during the study through the completion of adjuvant treatment and observation follow-up assessments

  11. Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 96 months

  12. Number and Severity of Surgical Related Adverse Events

    Time frame: Up to approximately 96 months

  13. Number of Surgical Delays

    Time frame: Up to approximately 96 months

    Number of surgical delays.

  14. Length of Surgical Delays

    Time frame: Up to approximately 96 months

    Length of surgical delays.

  15. Number of Operative and Post-Operative Complications

    Time frame: Up to approximately 96 months

    Number of operative and post-operative complications.

  16. Reasons for Surgical Cancellations

    Time frame: Up to approximately 96 months

    Reasons for surgical cancellations.

  17. Minimum Observed Serum Atezolizumab Concentration (Cmin)

    Time frame: Pre-dose on Day 1 of Cycles 1 and 3 (each cylce is 21 days) for Neoadjuvant Treatment; pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 (each cycle is 21 days) for Arm A; at treatment or observation follow-up discontinuation (up to approximately 96 months)

    Cmin is the minimum (or trough) concentration that a study drug achieves in the body.

  18. Maximum Observed Serum Atezolizumab Concentration (Cmax)

    Time frame: Pre-dose on Day 1 of Cycles 1 and 3 for Neoadjuvant Treatment; Pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 for Arm A. Each cycle is 21 days; at treatment or observation follow-up discontinuation (up to approximately 96 months)

    Cmax is the maximum (or peak) concentration that a study drug achieves in the body.

  19. Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab

    Time frame: Pre-dose on Day 1 of Cycles 1 and 3 for Neoadjuvant Treatment; Pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 for Arm A. Each cycle is 21 days; at treatment or observation follow-up discontinuation (up to approximately 96 months)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment With Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2018
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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