Ongoing Phase III Clinical Trials of Immunotherapy in Advanced Non–Small Cell Lung Cancer


To earn credit/contact hours, you must read all the articles in this supplement and then go to:
https://education.annenberg.net/IASLC

The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on immunotherapy in lung cancer. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.

Study Title: A Randomized, Double-Blind, Phase III Study of Platinum Plus Pemetrexed Chemotherapy With or Without Pembrolizumab (MK-3475) in First-Line Metastatic Nonsquamous Non–Small Cell Lung Cancer (NSCLC) Subjects (KEYNOTE-189)

Study Sponsor and Collaborators: Merck Sharp & Dohme Corp.

Purpose: To evaluate pembrolizumab combined with platinum/pemetrexed chemotherapy vs platinum/pemetrexed chemotherapy alone in participants with advanced or metastatic nonsquamous NSCLC who have not previously received systemic therapy for advanced disease

Primary Outcome Measures: Progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded central imaging [time frame: up to 24 months]

Principal Investigator: Medical Director, Merck Sharp & Dohme Corp; contact 1-888-577-8839

ClinicalTrials.gov Identifier: NCT02578680

***

Study Title: A Randomized, Open-Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) vs Platinum-Based Chemotherapy in Treatment-Naive Subjects With PD-L1–Positive Advanced or Metastatic NSCLC (KEYNOTE-042)

Study Sponsor and Collaborators: Merck Sharp & Dohme Corp.

Purpose: To study participants with programmed cell death ligand 1 (PD-L1)-positive NSCLC, who will be randomized to receive single-agent pembrolizumab for up to 35 treatments or standard-of-care platinum-based chemotherapy (carboplatin plus paclitaxel or carboplatin plus pemetrexed for four to six 21-day cycles). The primary study hypothesis is that pembrolizumab prolongs overall survival compared with standard-of-care chemotherapy.

Primary Outcome Measures: Overall survival [time frame: up to 2.5 years]

Principal Investigator: Medical Director, Merck Sharp & Dohme Corp.; contact 1-888-577-8839

ClinicalTrials.gov Identifier: NCT02220894

***

Study Title: A Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in First-Line Metastatic Squamous NSCLC Subjects (KEYNOTE-407)

Study Sponsor and Collaborators: Merck Sharp & Dohme Corp.

Purpose: To study carboplatin and paclitaxel or nanoparticle albumin-bound paclitaxel (nab-paclitaxel) with or without pembrolizumab in adults with first-line metastatic squamous NSCLC

Primary Outcome Measures: Progression-free survival per RECIST 1.1 as assessed by a blinded central imaging vendor [time frame: up to approximately 2 years]; overall survival [time frame: up to approximately 2 years]

Principal Investigator: Medical Director, Merck Sharp & Dohme Corp.; contact 1-888-577-8839

ClinicalTrials.gov Identifier: NCT02775435

***

Study Title: A Phase III, Open-Label, Randomized Study of MPDL3280A (Anti–PD-L1 Antibody) in Combination With Carboplatin Plus Paclitaxel With or Without Bevacizumab Compared With Carboplatin Plus Paclitaxel Plus Bevacizumab in Chemotherapy-Naive Patients With Stage IV Nonsquamous NSCLC (IMpower 150)

Study Sponsor and Collaborators: Hoffmann-La Roche

Purpose: To evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin and paclitaxel with or without bevacizumab compared with carboplatin plus paclitaxel and bevacizumab in chemotherapy-naive patients with stage IV nonsquamous NSCLC

Primary Outcome Measures: Progression-free survival as determined by the investigator using RECIST 1.1 [time frame: up to 2 years]

Principal Investigator: Clinical Trials, Hoffmann-La Roche; contact 888-662-6728, global.rochegenentechtrials@roche.com

ClinicalTrials.gov Identifier: NCT02366143

***

Study Title: A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of MPDL3280A (Anti–PD-L1 Antibody) in Combination With Carboplatin Plus Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Nonsquamous NSCLC (IMpower 130)

Study Sponsor and Collaborators: Hoffmann-La Roche

Purpose: To assess the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin plus nab-paclitaxel compared with treatment with carboplatin plus nab-paclitaxel in chemotherapy-naive patients with stage IV nonsquamous NSCLC

Primary Outcome Measures: Progression-free survival as determined by the investigator using RECIST 1.1 [time frame: up to 2.5 years]

Principal Investigator: Clinical Trials, Hoffmann-La Roche; contact 888-662-6728, global.rochegenentechtrials@roche.com

ClinicalTrials.gov Identifier: NCT02367781

***

Study Title: An Open-Label, Randomized Phase III Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-Doublet Chemotherapy vs Platinum-Doublet Chemotherapy in Subjects With Chemotherapy-Naive Stage IV or Recurrent NSCLC (CheckMate 227)

Study Sponsor and Collaborators: Bristol-Myers Squibb, Ono Pharmaceutical Co. Ltd

Purpose: To show that nivolumab, or nivolumab plus ipilimumab, or nivolumab plus platinum-doublet chemotherapy improves progression-free and/or overall survival compared with chemotherapy in subjects with advanced lung cancer

Primary Outcome Measures: Overall survival [time frame: approximately 48 months]; progression-free survival [time frame: approximately 40 months]

Principal Investigator: Bristol-Myers Squibb; visit clinicaltrials.gov to contact individual study locations

ClinicalTrials.gov Identifier: NCT02477826

***

Study Title: A Phase III Randomized, Open-Label, Multicenter, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy vs Standard-of-Care Platinum-Based Chemotherapy in First-Line Treatment of Patients With Advanced or Metastatic NSCLC (MYSTIC)

Study Sponsor and Collaborators: AstraZeneca

Purpose: To determine the efficacy and safety of MEDI4736 plus tremelimumab combination therapy and MEDI4736 monotherapy vs platinum-based standard-of-care chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC

Primary Outcome Measures: The efficacy of MEDI4736 plus tremelimumab combination therapy compared with standard of care in terms of progression-free and overall survival in patients with NSCLC [time frame: 3 years]

Principal Investigator: Naiyer Rizvi, MD, Columbia University Medical Center; visit clinicaltrials.gov for contact information for individual study locations

ClinicalTrials.gov Identifier: NCT02453282

***

Study Title: A Phase III Randomized, Open-Label, Multicenter, Global Study of MEDI4736 in Combination With Tremelimumab Therapy vs Standard-of-Care Platinum-Based Chemotherapy in First-Line Treatment of Patients With Advanced or Metastatic NSCLC (NEPTUNE)

Study Sponsor and Collaborators: AstraZeneca

Purpose: To determine the efficacy and safety of MEDI4736 plus tremelimumab combination therapy vs platinum-based standard-of-care chemotherapy in the first-line treatment of patients with EGFR and ALK wild-type advanced or metastatic NSCLC

Primary Outcome Measures: To assess the efficacy of MEDI4736 plus tremelimumab combination therapy compared with standard of care in terms of overall survival [time frame: up to 4 years after first patient randomized]

Principal Investigator: Tony Mok, MD, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT, Hong Kong; contact AstraZeneca Clinical Study Information Center, 1-877-240-9479, information.center@astrazeneca.com

ClinicalTrials.gov Identifier: NCT02542293 ■

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov



click me