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Hospital Nossa Senhora da Conceicao | Conceicao Hospital - Infectious Diseases Department

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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)

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Roche

Status and phase

Active, not recruiting
Phase 3

Conditions

Non-Small-Cell Lung

Treatments

Drug: Pemetrexed
Drug: Nab-paclitaxel
Drug: Carboplatin
Drug: Gemcitabine
Drug: Cisplatin
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Drug: Placebo Comparator

Study type

Interventional

Funder types

Industry

Identifiers

NCT03456063
GO40241

Details and patient eligibility

About

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.

Enrollment

453 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

453 participants in 2 patient groups, including a placebo group

Arm A: Atezolizumab + platinum-based chemotherapy
Experimental group
Description:
Neoadjuvant treatment will consist of 4 cycles; atezolizumab + platinum-based chemotherapy Platinum-based chemotherapy may include: carboplatin + pemetrexed carboplatin + nab-paclitaxel cisplatin + pemetrexed cisplatin + gemcitabine Post-operative adjuvant treatment will consist of 16-cycles of atezolizumab
Treatment:
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Drug: Cisplatin
Drug: Gemcitabine
Drug: Carboplatin
Drug: Nab-paclitaxel
Drug: Pemetrexed
Arm B: Placebo + platinum-based chemotherapy
Placebo Comparator group
Description:
Neoadjuvant treatment will consist of 4 cycles; placebo + platinum-based chemotherapy Platinum-based chemotherapy may include: carboplatin + pemetrexed carboplatin + nab-paclitaxel cisplatin + pemetrexed cisplatin + gemcitabine Participants will receive best supportive care and monitoring after surgery
Treatment:
Drug: Placebo Comparator
Drug: Cisplatin
Drug: Gemcitabine
Drug: Carboplatin
Drug: Nab-paclitaxel
Drug: Pemetrexed

Trial contacts and locations

127

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Data sourced from clinicaltrials.gov

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