Select Clinical Trials Currently Enrolling Patients with Lung Cancer

November 2016, Vol 6, No 11 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies that are currently recruiting patients with lung cancer for inclusion in investigations of new therapies or new regimens of existing treatments for patients with lung cancer. Each description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to an appropriate clinical trial.

1 Atezolizumab in Combination with Erlotinib or Alectinib in Participants with NSCLC

The purpose of this phase 1b, nonrandomized, single-group assignment, open-label clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of intravenous dosing of atezolizumab (Tecentriq) in combination with oral erlotinib or alectinib in participants with non–small-cell lung cancer (NSCLC). Men and women aged ≥18 years with a life expectancy of at least 12 weeks and with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive alectinib plus atezolizumab or erlotinib plus atezolizumab.

The primary outcome measure is the percentage of participants with dose-limiting toxicities. The secondary outcome measures include minimum plasma concentration of alectinib and its metabolites, progression-free survival (PFS), overall survival (OS), percentage of patients with at least 1 adverse event, percentage of participants with anti­therapeutic antibodies against ate-z­olizumab, and serum concentration of each of the drugs. This study plans to enroll 53 patients in the United States and abroad. For more information, call 888-662-6728 or e-mail global.rochegenentechtrials@roche.com. The NLM Identifier is NCT02013219.

2 Nivolumab versus Docetaxel in Previously Treated Advanced or Metastatic NSCLC: CheckMate 078

This randomized, open-label, parallel-assignment, phase 3 clinical trial assesses whether nivolumab improves life expectancy compared with docetaxel in patients with advanced or metastatic NSCLC who did not respond to previous platinum-based doublet chemotherapy. Men and women aged ≥18 years with disease progression during or after 1 previous platinum-containing doublet chemotherapy and with a performance status ≤1 may be eligible for enrollment if other criteria are met. Eligible patients will receive nivolumab or docetaxel.

The primary outcome measure is OS. The secondary outcome measures include objective response rate, PFS, and rate of disease-related symp­tom improvement. This study plans to enroll 500 patients at multiple locations abroad. For more information, contact Bristol-Myers Squibb at Clinical.Trials@bms.com. The NLM Identifier is NCT02613507.

3 Erlotinib Hydrochloride or Crizotinib plus Chemoradiation Therapy in Patients with Stage III NSCLC

This randomized, parallel-assignment, open-label phase 2 clinical trial evaluates the efficacy of erlotinib hydrochloride (Tarceva) plus chemoradiation versus crizotinib plus chemoradiation therapy in patients with stage III NSCLC. Men and women aged ≥18 years with unresectable stage IIIA or IIIB newly diagnosed nonsquamous NSCLC and with Zubrod performance status of 0 to 1 within 14 days before registration may be eligible for enrollment if other criteria are met. Eligible patients will receive erlotinib hydrochloride plus chemoradiation, chemoradiation in patients with EGFR tyrosine kinase mutation, crizotinib plus chemoradiation, or chemoradiation in patients with ALK mutation.

The primary objective is to compare PFS in patients with unresectable local-regionally advanced NSCLC who receive targeted agents based on molecular characteristics versus standard-care therapy. The secondary objectives include response rate, toxicity, OS, and correlation of clinical outcomes with tumor molecular aberrations. This study plans to enroll 234 patients in the United States. For more information, contact Ramaswamy Govindan at 314-362-4819. The NLM Identifier is NCT01822496.

4 Alectinib plus Bevacizumab in Patients with Advanced ALK-positive NSCLC

This open-label, single-group assignment, phase 1/2 study is evaluating the safety and efficacy of alectinib and bevacizumab (Avastin) for advanced NSCLC. Men and women aged ≥18 years with histologically confirmed advanced, nonsquamous NSCLC, with molecular confirmation of an ALK mutation and with a life expectancy of >12 weeks may be eligible for enrollment if other criteria are met. In the phase 1, dose-escalation portion of the study, patients will receive alectinib orally twice daily and bevacizumab intravenously. In phase 2, investigators will evaluate the combination of alectinib plus bevacizumab in ALK-positive NSCLC.

The primary outcome measures include the recommended phase 2 dose of alectinib plus bevacizumab and adverse events. The secondary outcome measures include central nervous system (CNS) objective response rate, CNS disease control rate, CNS PFS, overall objective response rate, overall disease control rate, PFS, and quality of life. This study plans to enroll 43 patients in Boston, MA. For more information, contact Justin Gainor, MD, at 617-724-4000 or jgainor@partners.org. The NLM Identifier is NCT02521051.

5 Atezolizumab in Combination with Carboplatin plus Nab-Paclitaxel for NSCLC: IMpower 130

This randomized, multicenter, open-label, phase 3 study is designed to evaluate the safety and efficacy of atezolizumab in combination with carboplatin plus nab-paclitaxel (Abraxane) versus that of carboplatin plus nab-paclitaxel in chemotherapy-naïve patients with stage IV nonsquamous NSCLC. Men and women aged ≥18 years with adequate hematologic and end-organ function and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Participants will receive atezolizumab plus nab-paclitaxel and carboplatin or nab-paclitaxel plus carboplatin.

The primary outcome measure is investigator-assessed PFS. The secondary outcome measures include objective response, OS, duration of response, PFS as determined by an independent review facility, time to deterioration, change from baseline in patient-reported lung cancer symptoms, and safety. This study expects to enroll 650 patients in the United States and abroad. For more information, contact Hoffmann-La Roche at 888-662-6728 or global.rochegenentechtrials@roche.com. The NLM Identifier is NCT02367781.

6 Brigatinib versus Crizotinib in Patients with ALK-positive Advanced NSCLC: ALTA-1L

This phase 3, randomized, open-label, parallel-assignment clinical trial assesses the safety and efficacy of brigatinib versus that of crizotinib (Alecensa) in patients with ALK mutation–positive NSCLC. Men and women aged ≥18 years with histologically or cytologically confirmed stage IIIB or stage IV NSCLC and an ECOG performance status of ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will receive brigatinib or crizotinib.

The primary outcome measure is PFS. The secondary outcome measures include objective response rate, intracranial objective response rate, intracranial PFS, OS, health-related quality of life, percentage of patients with adverse events, and steady-state pharmacokinetic parameters (eg, maximum plasma concentration, minimum plasma concentration, area under the curve, time to maximum plasma concentration, and apparent oral clearance). This study expects to enroll 270 patients at the University of Colorado Cancer Center. For more information, contact David Kerstein, MD, at 617-494-0400 or David.Kerstein@ARIAD.com; or Sergio Santillana, MD, at 617-494-0400 or Sergio.Santillana@ARIAD.com. The NLM Identifier is NCT02737501.

7 Alectinib versus Pemetrexed or Docetaxel in ALK-positive Advanced NSCLC After Platinum-Based Chemotherapy and Crizotinib

This randomized, active-controlled, multicenter, open-label, phase 3 study will assess the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who received chemotherapy and crizotinib, as measured by investigator-assessed PFS and to evaluate the CNS objective response rate in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee. Men and women aged ≥18 years with a histologically or cytologically confirmed diagnosis of advanced or recurrent (stage III) or metastatic (stage IV) ALK-positive NSCLC and with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Patients will receive alectinib or pemetrexed/docetaxel.

The primary outcome measure is PFS. The secondary outcome measures include objective response, disease control, duration of response, OS, median time to CNS progression, quality of life, and adverse events. This study expects to enroll 120 patients at multiple locations abroad. For more information, call 888-662-6728 or e-mail global.roche genentechtrials@roche.com. The NLM Identifier is NCT02604342.

8 Ensartinib versus Crizotinib in Patients with ALK-positive NSCLC

The primary purpose of this study is to evaluate the efficacy and safety of ensartinib versus crizotinib in patients with ALK-positive NSCLC who have received up to 1 chemotherapy regimen and no previous ALK inhibitor. Men and women aged ≥18 years with advanced or recurrent (stage IIIB not amenable for multimodality treatment) or metastatic (stage IV) ALK-positive NSCLC, and with a life expectancy of 12 weeks may be eligible for enrollment if other criteria are met. Patients will receive ensartinib or crizotinib.

The primary outcome measure is PFS. The secondary outcome measures include OS, objective response rate, PFS, time to response based on independent radiology review, time to response based on investigator assessment, duration of response based on independent radiology review, and duration of response based on investigator assessment. This study plans to enroll 402 patients in the United States. For more information, contact Jolee D. Holt, RN, at 918-899-1012 or jholt@optimalsites.net. The NLM Identifier is NCT02767804.

9 Nivolumab, Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy versus Platinum-Doublet Chemotherapy in Patients with Stage IV NSCLC: CheckMate 227

The purpose of this randomized, parallel-assignment, open-label study is to show that nivolumab (Opdivo), nivolumab plus ipilimumab (Yervoy), or nivolumab plus platinum-doublet chemotherapy improves PFS and/or OS compared with chemotherapy alone in patients with advanced lung cancer. Men and women aged ≥18 years with histologically confirmed stage IV or recurrent squamous or nonsquamous NSCLC who have not received previous systemic anticancer therapy may be eligible for enrollment if other criteria are met. Eligible patients will receive nivolumab alone, nivolumab plus ipilimumab, nivolumab plus platinum-doublet chemotherapy, or platinum-doublet chemotherapy.

The primary outcome measures are OS and PFS. The secondary outcome measures are objective response rate and disease-related symptom improvement. This study plans to enroll 1980 patients in the United States and abroad. For more information, contact Bristol-Myers Squibb at Clinical.Trials@bms.com. The NLM Identifier is NCT02477826.

10 Nivolumab After Surgery and Chemotherapy for Stage IB/IIIA NSCLC: ANVIL

This randomized, open-label, parallel-assignment, phase 3 clin-ical trial evaluates the efficacy of nivolumab after surgery and chemotherapy in patients with stage IB to IIIA NSCLC. Men and women aged ≥18 years who have undergone complete surgical resection of their stage IB, II, or IIIA NSCLC, and who have an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive nivolumab or no intervention.

The primary outcome measures include disease-free survival and OS. The secondary outcome measure is the incidence of toxicity graded according to the Common Terminology Criteria for Adverse Events, version 4.0. This study plans to enroll 714 patients in the United States. For more information, contact Francisco Robert at 205-934-0309. The NLM Identifier is NCT02595944.

11 Onartuzumab Combined with Erlotinib in Patients with MET-Positive NSCLC

This randomized, phase 3, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib compared with treatment with erlotinib alone in patients with incurable MET-positive NSCLC. Men and women aged ≥18 years with histologically confirmed incurable stage IIIB/IV NSCLC and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Patients will be randomized to receive erlotinib plus placebo or erlotinib plus onartuzumab.

The primary outcome measure is OS. The secondary outcome measures include PFS, health-related quality of life, and incidence of antitherapeutic antibodies against onartuzumab. This study expects to enroll 530 patients at multiple locations abroad. For more information, contact Hoffmann-La Roche at 888-662-6728 or global.rochegenentechtrials@roche.com. The NLM Identifier is NCT02031744.

12 ASP8273 versus Erlotinib or Gefitinib for First-Line Therapy of Stage IIIB/IV NSCLC with EGFR-Activating Mutations: SOLAR

The purpose of this randomized, parallel-assignment, open-label, phase 3 study is to evaluate the PFS of ASP8273 versus erlotinib or gefitinib (Iressa) in patients with locally advanced, metastatic or unresectable stage IIIB/IV NSCLC with EGFR activating mutations. Men and women aged ≥18 years with a predicted life expectancy ≥12 weeks, and with an ECOG ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ASP8273 or a daily dose of erlotinib or gefitinib.

The primary outcome measure is PFS. The secondary outcome measures include OS, best overall response rate, PFS as assessed by the investigator, disease control rate, duration of response, safety, and quality of life. This study plans to enroll 600 patients in the United States and abroad. For more information, contact Astellas Pharma Global Development at 800-888-7704 ext 5473, or Astellas.registration@astellas.com. The NLM Identifier is NCT02588261.

13 Cetuximab plus Afatinib for EGFR Mutation–Positive NSCLC: the ACE-Lung Study

The purpose of this phase 2, randomized, parallel-assignment, open-label study is to evaluate the combination of cetuximab (Erbitux) with afatinib (Gilotrif) as first-line treatment for patients with EGFR mutation–positive NSCLC. Men and women aged ≥18 years with stage III or IV NSCLC and with a performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive afatinib alone or afatinib plus cetuximab.

The primary outcome measure is the time to treatment failure. The secondary outcome measures include the number of participants with treatment-related adverse events, response rate, OS, and PFS. This study expects to enroll 170 patients at multiple locations in France. For more information, contact Elodie Amour or Franck Morin at contact@ifct.fr. The NLM Identifier is NCT02716311.

14 Necitumumab plus Nab-Paclitaxel and Carboplatin for Stage IV Squamous NSCLC

The purpose of this phase 2, open-label, single-group assignment study is to determine whether nab-paclitaxel and carboplatin chemotherapy plus necitumumab (Portrazza) is effective and safe in participants with stage IV squamous NSCLC. Men and women aged ≥18 years with stage IV NSCLC at the time of study enrollment and with a performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive necitum­umab plus nab-paclitaxel and carboplatin chemotherapy.

The primary outcome measure is the objective response rate. The secondary outcome measures include PFS, OS, disease control rate, pharmacokinetics, and immunogenicity. This study expects to enroll 50 patients in the United States and abroad. For more information, contact Eli Lilly and Company at 877-285-4559 or 317-615-4559. The NLM Identifier is NCT02392507.

15 Ramucirumab plus Erlotinib for EGFR-Positive Metastatic NSCLC: the RELAY Study

The purpose of this randomized, double-blind, parallel-assignment, phase 3 study is to evaluate the safety and efficacy of ramucirumab (Cyramza) in combination with erlotinib versus placebo in combination with erlotinib in participants with stage IV NSCLC harboring an activating EGFR mutation. Men and women aged ≥18 years with a life expectancy of at least 3 months may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ramucirumab plus erlotinib or placebo plus erlotinib.

The primary outcome measure is PFS and the number of participants with ≥1 drug-related adverse events or serious adverse events. The secondary outcome measures include OS, objective response rate, disease control rate, duration of response, pharmacokinetics, number of participants with anti-ramucirumab antibodies, change from baseline on the lung cancer symptom scale, and quality of life. This study expects to enroll 462 patients at multiple locations across the United States and abroad. For more information, contact Eli Lilly and Company at 877-285-4559 or 317-615-4559. The NLM Identifier is NCT02411448.

16 Osimertinib for NSCLC Harboring EGFR Mutations from Circulating Tumor DNA: LiquidLung-O

The purpose of this nonrandomized, parallel-assignment, open-label, phase 2 study is to evaluate the efficacy of osimertinib (Tagrisso) in patients with lung cancer harboring activating EGFR mutations (cohort 1) and those harboring T790M mutations (cohort 2), which were detected from circulating tumor DNA. Men and women aged ≥19 years with EGFR mutation or with a T790M mutation, and with a World Health Organization performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Patients in both cohorts will receive osimertinib.

The primary outcome measure is efficacy. The secondary outcome measures include sensitivity of testing methods, PFS, duration of response, and adverse events. This study expects to enroll 38 patients in Korea. For more information, contact Young-Chul Kim, MD, PhD, at kyc0923@jnu.ac.kr. The NLM Identifier is NCT02769286.