The following clinical trials represent a selection of key studies currently recruiting patients with lung cancer for inclusion in investigations of new therapies and new regimens of existing treatments for the disease. Each clinical trial 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 one of these clinical trials.
1 Nazartinib plus Gefitinib in TKI-Naïve Advanced NSCLC and EGFR Mutation
The purpose of this phase 2 clinical trial is to assess the combination of the investigational drug nazartinib (EGF816) plus gefitinib (Iressa) as a possible treatment for patients with tyrosine-kinase inhibitor-naïve non–small-cell lung cancer (NSCLC) with EGFR mutation. Patients aged ≥18 years with pathologically confirmed advanced NSCLC who have not received more than 1 previous line of chemotherapy or immunotherapy in the metastatic setting and who have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will receive nazartinib plus gefitinib orally (PO) once daily and be required to maintain a medication diary of each dose.
The primary outcome measure is progression-free survival (PFS) at 9 months, and the secondary outcome measures are response rate, overall survival (OS), and the safety and tolerability of the combination at 2 years. This study expects to enroll 36 participants in the Boston, MA, area. For more information, contact Beth Kennedy at the Massachusetts General Hospital at 1-617-724-1223 or
2 Permanent Implanted Low-Dose Rate CivaSheet for Treatment of Lung Cancer
The purpose of this phase 2 clinical trial is to determine the efficacy of CivaSheet, a unidirectional low-dose rate brachytherapy device that utilizes palladium-103 in a novel configuration that reduces the radiation dose of critical body structures while administering therapeutic doses to diseased tissue in patients with stage I or II NSCLC. Patients aged ≥18 with NSCLC in the upper lobes of either lung with tumor mass ≤7 cm in diameter as determined by chest CT scan with more than 5 years since previous invasive malignancy may be eligible for enrollment if other criteria are met. Eligible patients will receive the implanted CivaSheet to have high doses of radiation delivered to targeted areas while preventing the dose to affect healthy tissue or critical structures.
The primary outcome measure is local control rate in the region of the CivaSheet at 1 year. The secondary outcome measures are freedom from regional or distant recurrence, time to recurrence, and toxicity graded on Common Terminology Criteria for Adverse Events 4.0 scale. This study expects to enroll 40 participants in the New York and California areas. For more information, contact Carra Castagnero at 1-919-314-5515 or
3 Anamorelin Hydrochloride to Reduce Anorexia in Patients with Advanced NSCLC
The purpose of this randomized phase 2/3 clinical trial is to assess the effectiveness of anamorelin hydrochloride in the reduction of anorexia and weight loss in patients with advanced metastatic NSCLC. Patients aged ≥18 years with advanced NSCLC with Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale (FAACT A/CS) domain score ≤37 with a history of either ≥5% weight loss for patients with a body mass index ≥20 kg/m2 or ≥2% weight loss for patients with a body mass index <20 kg/m2, and a life expectancy of ≥6 months may be eligible if other criteria are met. Eligible patients will be randomized to receive anamorelin hydrochloride PO daily for 9 weeks or placebo PO daily for 9 weeks in the absence of disease progression or unacceptable toxicity.
The primary outcome measure is change in anorexia/cachexia as determined by the FAACT A/CS domain with correlation of the 5-item Anorexia Symptom Scale and the Spearman Correlation. The secondary outcome measures are descriptive statistics of the effectiveness of anamorelin hydrochloride, daily psychosocial function, independence, and anorexia experiences. This trial expects to enroll 40 participants at the University of Texas M.D. Anderson Cancer Center, Houston. For more information, contact Sriram Yennu, MD, at 1-713-792-6085 or
4 Bintrafusp Alfa versus Pembrolizumab as First-Line Treatment for PD-L1–Positive Advanced NSCLC
The purpose of this randomized, open-label phase 3 clinical trial is to evaluate the efficacy and safety of bintrafusp alfa (M7824) versus pembrolizumab (Keytruda) in patients with advanced NSCLC with high PD-L1 tumor expression without EGFR mutation or ALK translocation. Patients aged ≥18 years with histologically confirmed advanced NSCLC who have not received previous systemic treatment; or who have completed cytotoxic chemotherapy, biological therapy, and/or radiation at least 6 months before diagnosis of metastatic disease; has PD-L1 high status; and who have a life expectancy of at least 3 months may be eligible if other criteria are met. Eligible patients will be randomized to receive bintrafusp alfa 1200 mg intravenous (IV) once every 2 weeks until disease progression or pembrolizumab 200 mg IV once every 3 weeks until disease progression.
The primary outcome measures are PFS and OS from randomization to planned final assessment at approximately 60 months. Secondary outcome measures include occurrences of treatment-emergent adverse events, objective response, duration of response (DOR) from complete response or partial response, and immunogenicity. This trial expects to enroll 584 patients in the United States and internationally. For more information, contact EMD Serono’s Medical Information at 1-888-275-7376 or
5 Pembrolizumab plus Lenvatinib versus Pembrolizumab Alone in Treatment-Naïve Metastatic NSCLC and PD-L1 Expression
The purpose of this randomized, double-blind, phase 3 clinical trial is to examine the safety and efficacy of pembrolizumab plus lenvatinib (Lenvima) versus pembrolizumab monotherapy in patients with treatment-naïve, metastatic NSCLC with PD-L1 Tumor Proportion Score ≥1%. Patients aged ≥18 years with histologically or cytologically confirmed stage IV NSCLC with PD-L1 expression in ≥1% of tumor cells, an ECOG performance status of 0 or 1 within 7 days before first study dose, and adequate organ function and controlled blood pressure may be eligible if other criteria are met. Eligible patients will be randomized to receive pembrolizumab 200 mg IV plus lenvatinib 20 mg PO once daily or pembrolizumab 200 mg IV plus placebo until progressive disease or unacceptable toxicity.
The primary outcome measures are PFS from the date of randomization to progressive disease or death (whichever comes first) and OS from date of randomization to date of death from any cause. Secondary outcome measures include overall response rate (ORR), number of participants who discontinue study treatment because of adverse events, and change in baseline and time to true deterioration in physical functioning, global health status, and quality of life. This trial expects to enroll 620 patients in the United States and worldwide. For more information, contact Merck Sharp & Dohme Corp at 1-888-577-8839 or
6 Durvalumab Alone versus Tremelimumab plus Durvalumab in Limited-Stage SCLC Following Concurrent Chemoradiation Therapy
The purpose of this randomized, double-blind, phase 3 clinical trial is to assess the efficacy of durvalumab (Imfinzi) monotherapy versus tremelimumab plus durvalumab in patients with limited-stage small-cell lung cancer (SCLC) whose disease has not progressed following concurrent chemoradiation therapy. Patients aged ≥18 years with histologically or cytologically diagnosed disease, who received 4 previous cycles of chemotherapy concurrent with radiotherapy within 1 to 42 days before randomization, and who have an ECOG score of 0 or 1 may be eligible if other criteria are met. Eligible patients will be randomized to receive either durvalumab monotherapy 1500 mg IV plus placebo every 4 weeks versus durvalumab 1500 mg plus tremelimumab 75 mg IV every 4 weeks versus placebo IV every 4 weeks.
The primary outcome measures are PFS and OS in 5 years. Secondary outcome measures include PFS at 18 and 24 months, time to death or distant metastasis, proportion of patients alive at 24 and 36 months, time from randomization to second progression, and to assess the relationship between tumor mutational burden and PFS, ORR, and OS. This study expects to enroll 600 patients in the United States and worldwide. For more information, contact AstraZeneca Clinical Study Information Center at 1-877-240-9479 or
7 Atezolizumab plus Carboplatin and Etoposide with or without Tiragolumab in Untreated Extensive-Stage SCLC
The purpose of this randomized, double-blind, phase 3 clinical trial is to assess the efficacy of tiragolumab (MTIG7192A) plus atezolizumab (Tecentriq) plus etoposide and carboplatin (EC) versus placebo plus atezolizumab plus EC in patients with chemotherapy-naïve extensive-stage SCLC. Patients aged ≥18 years with histologically or cytologically confirmed disease with an ECOG status of 0 or 1, who have adequate hematologic and end-organ function, and who have been treatment-free for at least 6 months since previous chemoradiation and have had no previous systemic treatment may be eligible if other criteria are met. Eligible patients will be randomized in a 1:1 ratio to receive tiragolumab plus atezolizumab plus EC versus placebo plus atezolizumab plus EC, and patients will continue maintenance therapy with either atezolizumab plus tiragolumab or atezolizumab plus placebo following induction phase.
The primary outcome measures are investigator-assessed PFS and OS up to 43 months. Secondary outcome measures include investigator-assessed ORR and DOR, OS at 12 and 24 months, time to confirmed deterioration, Cmax of atezolizumab and percentage with antidrug antibodies, and Cmax of tiragolumab and percentage with antidrug antibodies. This trial expects to enroll 400 eligible patients in the United States and worldwide. For more information, contact Hoffmann-La Roche at 1-888-662-6728 or
8 Adjuvant Canakinumab in Completely Resected Stages II-IIIA and IIIB NSCLC
The purpose of this randomized, double-blind, phase 3 clinical trial is to assess the efficacy and safety of canakinumab (Ilaris) versus placebo as adjuvant therapy in patients with completely resected American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) version 8 stage II-IIIA and IIIB NSCLC. Patients aged ≥18 years with an ECOG status of 0 or 1, who have recovered from all toxicities related to previous systemic therapy, and who have completely resected AJCC/UICC version 8 stage IIA-IIIA and IIIB or those with stage IIA-IIIA and IIIB who are candidates for complete resection surgery may be eligible if other criteria are met. Eligible patients will be randomized to receive canakinumab for 18 cycles (54 weeks) versus placebo for 18 cycles (54 weeks).
The primary outcome measure is investigator-assessed disease-free survival or death because of any cause. Secondary outcome measures include OS; lung cancer–specific survival; serum concentrations of immunogenicity of canakinumab; time to definitive 10-point deterioration symptom scores of pain, cough, and dyspnea; and time to definitive deterioration in global health status/quality of life. This trial expects to enroll 1500 patients in the United States and worldwide. For more information, contact Novartis Pharmaceuticals at 1-888-669-6682 or