Targeted therapy and immunotherapy studies for people with lung cancer

February 22, 2017

More than 20 studies of promising new therapies for lung cancer patients are open now at Providence Cancer Center, including studies of targeted therapies and novel immunotherapy combinations. Some of these studies are open to patients who have received prior immunotherapy. The following featured studies are either specifically for lung cancer, or for multiple types of cancer, including lung cancer:  

Lung cancer studies:

Title: A Phase I/II Study of MK-3475 with Gemcitabine in Patients with Previously-Treated Advanced Non-small Cell Lung Cancer (NSCLC) (Currently enrolling in the phase II portion.)

Description: This study is an open-label, non-randomized phase I study, followed by an open-label non-randomized phase II study. The first cohort of patients will receive 200 milligrams (mg) of MK-3475 by intravenous infusion over a 21-day period, called a cycle, along with gemcitabine 1250 mg/m2 given on Days 1 and 8 of each 21-day cycle for up to 6 cycles. Patients will be seen in the study clinic 12 times over 126 days for an evaluation of signs and symptoms that may represent drug toxicity. Patients may continue to receive MK-3475 (without gemcitabine) for up to 2 years.

Title: A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination with Carboplatin or Cisplatin + Pemetrexed Compared with Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer

Description: This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (atezolizumab + carboplatin or cisplatin + pemetrexed) and Arm B (carboplatin or cisplatin + pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase.

Title: An Open-Label Phase 1/2 Study of INCB039110 in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Note: This study is for patients with EGFR mutations who have progressed on an EGFR inhibitor.

Description: The purpose of this study is to evaluate the safety and tolerability of INCB039110 in combination with osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Studies for multiple types of cancer, including lung cancer:

Title: A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (Lirilumab) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors

Description: The purpose of this study is to assess the safety and tolerability and preliminary anti-tumor activity of lirilumab/BMS-986015 given in combination with nivolumab/BMS-936558 and to identify dose-limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination, in subjects with advanced (metastatic and/or unresectable) solid tumors.

Title: Open-label, Multicenter Phase 1/2 Study of Mogamulizumab in Combination with Nivolumab in Subjects with Locally Advanced or Metastatic Solid Tumors

Description: This is a multicenter, Phase 1/2 open-label, dose-finding and cohort expansion study of the anti-CCR4 antibody mogamulizumab in combination therapy with the anti-PD-1 antibody nivolumab in adult subjects with locally advanced or metastatic solid tumors.

Title: A Phase 1/2, Open-Label, Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of CD122-Biased Cytokine (NKTR-214) and Anti-PD-1 Antibody (Nivolumab) in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies

Description: This study is to determine first, the recommended Phase 2 dose of NKTR-214 when administered in combination with nivolumab, and then, the clinical benefit, safety, and tolerability of combining NKTR-214 with nivolumab in select patients with melanoma, renal cell carcinoma or non-small cell lung cancer. Both drugs target the immune system and may act synergistically to promote anti-cancer effects.

Title: A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

Description: The purpose of this study is to assess the safety and tolerability, characterize the dose-limiting toxicities, and identify the maximum tolerated dose of BMS-986016 alone and in combination with nivolumab in subjects with select advanced (metastatic and/or unresectable) solid tumors and to provide preliminary information on the clinical benefits of the combination.

Title: A Phase 1, Open-label, Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies

Description: This study will examine the safety profile of SEA-CD40. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens may also be evaluated to see if more SEA-CD40 can be given within a treatment cycle while maintaining an acceptable safety profile. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.

Title: A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination With Ipilimumab in Patients With B7-H3-Expressing Melanoma, Squamous Cell Cancer of the Head and Neck, Non-Small Cell Lung Cancer, and Other B7-H3 Expressing Cancers

Description: The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Yervoy (ipilimumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC) and other B7-H3 expressing cancers. The study will also evaluate what is the best dose of enoblituzumab to use when given with ipilimumab. Assessments will also be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity of enoblituzumab in combination with ipilimumab.