Select Ongoing Trials Currently Enrolling Patients with Lung Cancer

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 Ociperlimab plus Tislelizumab versus Pembrolizumab plus Placebo in Locally Advanced, Untreated NSCLC

The purpose of this randomized, double-blind, phase 3 study is to compare the progression-free survival (PFS) and overall survival (OS) rates associated with the combination of ociperlimab (BGB-A1217), an anti-TIGIT antibody, plus tislelizumab (BGB-A317), a humanized IgG4 anti–PD-1 monoclonal antibody, versus pembrolizumab (Keytruda) plus placebo in patients with previously untreated, PD-L1–positive, and locally advanced, unresectable, or metastatic non–small-cell lung cancer (NSCLC). Patients aged ≥18 years with histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definite radiotherapy, who have had no previous systemic treatment, who have tumors with PD-L1 tumor cell ≥50% expression, who have at least 1 measurable lesion as defined per RECIST version 1.1, and who have an Eastern Cooperative Oncology Group (ECOG) performance status ≤1 may be eligible if other criteria are met. Eligible patients will be randomized to receive either ociperlimab 900 mg intravenously (IV) followed by tislelizumab 200 mg IV once every 3 weeks, or pembrolizumab 200 mg IV plus placebo IV once every 3 weeks.

The primary outcome measures are PFS, defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST version 1.1 or death, whichever occurs first, and OS, defined as the time from the date of randomization to the date of death due to any cause. Secondary outcome measures include overall response rate (ORR), duration of response (DOR), health-related quality of life (QOL) as assessed by patient-reported outcomes (PROs) using the European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), time to deterioration, and the number of participants having adverse events (AEs). The study plans to enroll 605 participants throughout the United States and worldwide. For more information, contact BeiGene at 1-877-828-5568 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04746924.

2 Atezolizumab in Combination with Tiragolumab versus Durvalumab in Stage III, Locally Advanced, Unresectable NSCLC

The purpose of this randomized, open-label, phase 3 study is to evaluate the efficacy and safety of atezolizumab (Tecentriq) in combination with tiragolumab (MTIG7192A) versus durvalumab (Imfinzi) in the treatment of patients with locally advanced, unresectable, stage III NSCLC who have received ≥2 cycles of concurrent platinum-based chemoradiotherapy (CRT) and who have not had radiographic disease progression. Patients aged ≥18 years with histologically or cytologically documented stage III NSCLC of either squamous or nonsquamous histology, who have an ECOG performance status of 0 or 1, who have had no disease progression during or following concurrent platinum-based CRT, who have had ≥2 previous cycles of platinum-based chemotherapy administered concurrently with radiotherapy completed within 1 to 42 days prior to randomization, and who have a known PD-L1 result may be eligible if other criteria are met. Eligible participants will be randomized to receive treatment with either atezolizumab 1680 mg IV followed by tiragolumab 840 mg IV every 4 weeks on day 1 of each 28-day cycle, or durvalumab 10 mg/kg IV every 2 weeks on days 1 and 15 of each 28-day cycle.

The primary outcome measure is independent review facility–assessed PFS. Secondary outcome measures include OS, investigator-assessed PFS, confirmed objective response rate, DOR, time to death or distant metastasis, time to confirmed deterioration, percentage of participants with AEs, and percentage of participants with antidrug antibodies to tiragolumab and to atezolizumab. The study plans to enroll 800 participants throughout the United States and worldwide. For more information, contact Hoffmann-La Roche at 1-888-662-6728 or This email address is being protected from spambots. You need JavaScript enabled to view it. and mention study ID GO41854. The NLM identifier is NCT04513925.

3 Concurrent CRT plus Pembrolizumab Followed by Pembrolizumab with or Without Olaparib in Newly Diagnosed, Treatment-Naïve, Limited-Stage SCLC

The purpose of this randomized, double-blind, placebo-controlled, phase 3 study is to compare the OS and PFS of concurrent CRT plus pembrolizumab (Keytruda) followed by pembrolizumab with or without olaparib (Lynparza) in the treatment of patients with newly diagnosed, treatment-naïve, limited-stage, small-cell lung cancer (SCLC). Patients aged ≥18 years with pathologically confirmed SCLC with at least 1 measurable lesion, who have not received any previous treatment (chemotherapy or radiotherapy or surgery resection) for limited-stage SCLC who are not expected to require tumor resection during the course of the study, and who have an ECOG performance score of 0 or 1 may be eligible if other criteria are met. Eligible participants will be randomized to receive 4 cycles of standard-of-care chemotherapy plus either pembrolizumab 200 mg every 3 weeks concurrently with CRT, followed by 9 cycles of pembrolizumab 400 mg every 6 weeks plus placebo twice daily; pembrolizumab 200 mg every 3 weeks concurrently with CRT, followed by 9 cycles of pembrolizumab 400 mg every 6 weeks plus olaparib 300 mg twice daily; or placebo.

The primary outcome measures are PFS per RECIST version 1.1 and OS from the time of randomization to death due to any cause. Secondary outcome measures include the number of participants having AEs and the number of participants discontinuing study treatment due to AEs, the percentage of participants having either a confirmed response or partial response, DOR, and change from baseline of EORTC QLQ-C30. The study plans to enroll 672 participants throughout the United States and worldwide. For more information, contact Merck Sharp & Dohme at 1-888-577-8839 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04624204.

4 Lurbinectedin Alone or in Combination with Irinotecan versus Topotecan or Irinotecan in Relapsed SCLC

The purpose of this multicenter, open-label, randomized, controlled, phase 3 clinical trial is to evaluate and compare the efficacy and safety of lurbinectedin (Zepzelca) as monotherapy or in combination with irinotecan versus investigator’s choice of topotecan (Hycamtin) or irinotecan in patients with SCLC. Patients aged ≥18 years with histologically or cytologically confirmed SCLC, who have received 1 previous line of platinum-containing chemotherapy with or without anti–PD-1 or anti–PD-L1 treatment, who have an ECOG performance status ≤2, who have recovery to grade ≤1 from any AE at least 3 weeks since previous antineoplastic treatment, and who have had prophylactic cranial irradiation at least 2 weeks prior to randomization may be eligible if other criteria are met. Eligible patients will be randomized to receive either lurbinectedin 3.2 mg/m² IV on day 1 every 3 weeks; lurbinectedin 2.0 mg/m² on day 1 every 3 weeks plus irinotecan 75 mg/m² IV on days 1 and 8 every 3 weeks; or investigator’s choice of irinotecan 350 mg/m² IV on day 1 every 3 weeks or topotecan 2.3 mg/m² orally or 1.5 mg/m² IV on days 1 to 5 every 3 weeks.

The primary outcome measure is OS from the date of randomization to the date of death or last contact. Secondary outcome measures include PFS rate at 6, 12, and 39 months; ORR; OS rate at 12 and 24 months; DOR; and PROs at baseline and every 6 weeks until end of treatment up to 39 months. The study plans to enroll 705 participants throughout the United States and worldwide. For more information, contact José Antonio Lopez-Vilariño, MD, at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05153239.

5 Durvalumab in Combination with Oleclumab or Monalizumab After Concurrent CRT in Stage III, Locally Advanced, Unresectable NSCLC

The purpose of this multicenter, randomized, double-blind, placebo-controlled, phase 3 study is to assess the efficacy and safety of durvalumab (Imfinzi) in combination with oleclumab (MEDI9447) or monalizumab (IPH2201) in patients with locally advanced, unresectable NSCLC, whose disease has not progressed following platinum-based CRT. Patients aged ≥18 years with histologically or cytologically documented NSCLC who have been treated with ≥2 cycles of concurrent CRT for stage III disease; who have documented tumor PD-L1, EGFR, and ALK wild-type status; who have a World Health Organization performance status of 0 or 1 at randomization; and who have adequate organ and marrow function may be eligible if other criteria are met. Eligible patients will be randomized to receive either durvalumab IV on day 1 of each 28-day cycle plus oleclumab IV on days 1 and 15 of cycles 1 and 2, then on day 1 of each 28-day cycle for up to 12 months; durvalumab IV and monalizumab IV on day 1 of each subsequent 28-day cycle for up to 12 months plus placebo IV on day 15 of cycles 1 and 2; or durvalumab IV on day 1 of each 28-day cycle plus placebo IV on days 1 and 15 of cycles 1 and 2, then on day 1 of each subsequent 28-day cycle for up to 12 months.

The primary outcome measure is PFS from time of randomization up to 5 years. Secondary outcome measures include OS at 24 months and up to 9 years; objective response rate; DOR; PFS at 6, 12 18, and 24 months; time from randomization to date of distant metastasis or death and to start date of first subsequent therapy; time to deterioration in pulmonary symptoms; and antidrug antibodies of durvalumab, oleclumab, and monalizumab until 3 months after date of last dose. The study plans to enroll 999 participants throughout the United States and worldwide. For more information, contact AstraZeneca Clinical Study Information Center at 1-877-240-9479 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05221840.

6 N-803 plus Current Standard of Care versus Standard of Care as First-Line Treatment of Stage III or IV NSCLC

The purpose of this randomized, open-label, 3-cohort, phase 3 study is to compare the safety and efficacy of N-803 (Anktiva) in combination with the current standard of care versus standard of care alone as first-line treatment of patients with stage III or IV, advanced or metastatic NSCLC. Patients aged ≥18 years with histologically confirmed stage III or IV disease who are not candidates for treatment with surgical resection or CRT, who have not received previous systemic chemotherapy for advanced or metastatic disease, who have an ECOG performance status of 0 or 1, who have measurable tumor lesions per RECIST version 1.1, and whose tumor does not have an EGFR sensitizing mutation or ALK translocation or targetable genomic aberration in BRAF, ROS1, or NTRK may be eligible if other criteria are met. Eligible participants will be randomized to receive either N-803 15 μg/kg subcutaneously plus pembrolizumab (Keytruda) 200 mg IV; N-803, carboplatin, nab-paclitaxel (Abraxane), and pembrolizumab as induction therapy, followed by N-803 plus pembrolizumab 200 mg IV on day 1 every 3 weeks as maintenance therapy; or N-803, cisplatin or carboplatin, pembrolizumab, and pemetrexed as induction therapy, followed by N-803 plus pembrolizumab 200 mg IV maintenance therapy.

The primary outcome measure is PFS per RECIST version 1.1 up to 24 months. Secondary outcome measures include OS, ORR, and DOR per RECIST version 1.1; PFS, ORR, and DOR per iRECIST; disease control rate, defined as confirmed complete response, partial response, or stable disease lasting for at least 2 months per RECIST version 1.1; and QOL based on PRO questionnaires. The study plans to enroll 1538 participants throughout the United States. For more information, contact Paula Bradshaw at 1-844-413-8500 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Brooke Greenley at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03520686.

7 Lurbinectedin in Combination with Atezolizumab versus Atezolizumab Alone as Maintenance in Extensive-Stage SCLC

The purpose of this randomized, open-label, multicenter, phase 3 study is to study the efficacy and safety of lurbinectedin (Zepzelca) in combination with atezolizumab (Tecentriq) versus atezolizumab alone as maintenance therapy in the treatment of extensive-stage SCLC after first-line induction therapy with carboplatin, etoposide, and atezolizumab. Patients aged ≥18 years with an ECOG performance status of 0 or 1, who have not received any previous systemic therapy for their disease, and who have been treatment-free for at least 6 months may be eligible for the induction phase of the study if other criteria are met. Patients aged ≥18 years with an ECOG performance status of 0 or 1, who have an ongoing or stable disease per RECIST version 1.1 after 4 cycles of induction therapy, and who have adequate hematologic and end-organ function may be eligible for the maintenance phase of the study if other criteria are met. Eligible participants in the induction phase of the study will receive atezolizumab 1200 mg IV on day 1 of each 21-day cycle in combination with carboplatin on day 1 and etoposide on days 1 to 3 of each 21-day cycle for 4 cycles. Eligible participants in the maintenance phase of the study will be randomized 1:1 to receive either atezolizumab 1200 mg IV plus lurbinectedin 3.2 mg/m² IV on day 1 of each 21-day cycle, or atezolizumab 1200 mg IV monotherapy on day 1 of each 21-day cycle.

The primary outcome measures include independent review facility–assessed PFS and OS from time of randomization to the first occurrence of disease progression or death due to any cause. Secondary outcome measures include investigator-assessed PFS, confirmed objective response rate, DOR, the percentage of participants with AEs and antidrug antibodies to atezolizumab, and time to confirmed deterioration. The study plans to enroll 690 participants throughout the United States and worldwide. For more information, contact Hoffmann-La Roche at 1-888-662-6728 or This email address is being protected from spambots. You need JavaScript enabled to view it., and mention reference study ID number GO43104. The NLM identifier is NCT05091567.

8 Addition of Pembrolizumab to Usual Chemotherapy in Resected Stage IIA-IIIB NSCLC

The purpose of this randomized, open-label, phase 3 study is to evaluate the efficacy, safety, and tolerability of adding pembrolizumab (Keytruda) to the usual chemotherapy treatment regimen for resected stage IIA, IIB, IIIA, or IIIB NSCLC. Patients aged ≥18 years with an ECOG performance status of 0 or 1; who have had complete recovery from surgery with completely resected disease; who have had no previous neoadjuvant or adjuvant therapy for current disease or previous allogeneic tissue or solid organ transplantation; who have had central and/or local testing of EGFR with no EGFR exon 19 deletion or EGFR L858R mutation, ALK with no ALK rearrangement, and PD-L1 immunohistochemistry; and who do not have any currently active second malignancies that are progressing or that required treatment within the past 3 years may be eligible if other criteria are met. Eligible participants will currently be randomized to receive 1 of 14 platinum double regimens every 21 days for 4 cycles in the initial therapy phase of Arm B, followed by pembrolizumab IV on day 1 every 6 weeks for 16 cycles in the maintenance phase of Arm B; or 1 of 14 platinum double regimens plus pembrolizumab IV on day 1 every 21 days for 4 cycles in the initial therapy phase of Arm C, followed by pembrolizumab IV on day 1 every 6 weeks for 12 cycles in the maintenance phase of Arm C.

The primary outcome measure is disease-free survival (DFS) from date of randomization to disease recurrence or death due to any cause, assessed up to 5 years after accrual completion. Secondary outcome measures include OS, the incidence of AEs, and the DFS and OS rate between each experimental arm versus standard of care. The study plans to enroll 1210 participants throughout the United States and worldwide. For more information, contact the recruiting sites directly. The NLM identifier is NCT04267848.

9 Niraparib plus Pembrolizumab versus Pembrolizumab plus Placebo as Maintenance Therapy in Advanced or Metastatic NSCLC

The purpose of this multicenter, randomized, double-blind, placebo-controlled, phase 3 study is to compare the efficacy and safety of niraparib (Zejula) plus pembrolizumab (Keytruda) versus pembrolizumab plus placebo as maintenance therapy in patients with stage IIIB/IIIC or IV NSCLC whose disease remained stable or responded to first-line platinum-based chemotherapy. Patients aged ≥18 years with histologically or cytologically confirmed advanced or metastatic disease; who have completed at least 4 but no more than 6 cycles of standard-of-care, first-line, platinum-based induction chemotherapy with pembrolizumab; who have an ECOG performance status of 0 or 1; and who have a life expectancy of at least 12 weeks may be eligible if other criteria are met. Eligible participants will be randomized to receive either niraparib plus pembrolizumab or pembrolizumab plus placebo.

The primary outcome measures are PFS from date of randomization to date of first radiographic disease progression per RECIST version 1.1 or death due to any cause in the absence of progression, whichever occurs first, and OS. Secondary outcome measures include time to progression in the central nervous system; PFS by investigator assessment and by PD-L1 status; OS by PD-L1 status; time to deterioration in lung symptoms; the change in baseline in health-related QOL and symptoms per EORTC QLQ-C30 and -Lung Cancer 13; the number of participants with AEs, serious AEs, and AEs of special interest; and plasma concentrations of niraparib. The study plans to enroll 650 participants throughout the United States and worldwide. For more information, contact the GlaxoSmithKline Clinical Trials Call Center at 1-877-379-3718 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04475939.