Lung Cancer Clinical Trials & Research at St. Joseph Health Medical Group

The two main types of lung cancer are non-small cell lung cancer and small cell lung cancer. The types are based on the way the cells look under a microscope. Non-small cell lung cancer is much more common than small cell lung cancer. Tobacco smoking is the most common cause of lung cancer.

St. Joseph Health Medical Group is currently enrolling patients for the following lung cancer clinical trials:

Non-Small Cell Lung Cancer
Small Cell Lung Cancer


Non-Small Cell Lung Cancer

A Phase III, Double-blind, Randomized, Placebo-Controlled Multi-centre, study to assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA)

Phase III

The goals of this study is to assess the efficacy and safety of study drug versus placebo in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy. Adjuvant chemotherapy should have consisted of a platinum-based doublet given for a maximum of 4 cycles. Patients must have sufficiently recovered from surgery and completed any standard of care adjuvant chemotherapy prior to randomization.

Treatment agent: Osimertinib
PI: Ian Anderson, MD
Study Coordinator: Tracy Foster // Tracy.Foster@stjoe.org // (707) 521-3836
Resources and Links: clinicaltrials.gov NCT No: NCT02511106

A Phase III, randomized, double-blind, placebo-controlled, multicenter, international study of osimertinib as maintenance therapy in patients with locally advanced, unresectable EGFR mutation-positive Non-Small Cell Lung Cancer (Stage III) whose disease has not progressed following definitive platinum-based chemoradiation therapy (LAURA)

Phase III

The goal of this double-blind, placebo-controlled study is to assess the efficacy and safety of osimertinib, as maintenance therapy in patients with locally advanced, unresectable epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer (Stage III), whose disease has not progressed following definitive platinum based- chemoradiation therapy.

Treatment agent: Osimertinib
PI: Ian Anderson, MD
Study Coordinator: Tracy Foster // Tracy.Foster@stjoe.org // (707) 521-3836
Resources and Links: clinicaltrials.gov NCT No: NCT03521154

Phase 1b/2 Safety, Pharmacokinetic, and Efficacy Study of G1T38 in Combination with Osimertinib in Patients with EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (G1T38)

Phase Ib/II

The goals of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of G1T38 in combination with osimertinib for patients with EGFR mutation-positive metastatic NSCLC. This study consists of 2 parts: Part 1 will evaluate the effect of osimertinib on the PK parameters of G1T38 and the safety and tolerability of escalating doses of G1T38 in combination with osimertinib to determine the recommended Phase 2 dose; and Part 2 will be a randomized portion to further evaluate the safety, tolerability, and efficacy of the recommended Phase 2 dose.

Treatment agent: G1T38 (CDK4/6 inhibitor) +/- Osimertinib
PI: Ian Anderson, MD
Study Coordinator: Tracy Foster // Tracy.Foster@stjoe.org // (707) 521-3836
Resources and Links: clinicaltrials.gov NCT No: NCT03455829

A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy with or without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)

Phase III

The goals of this study is to compare the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab in the treatment of adults with the following types of EGFR mutation-positive, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status.

Treatment agent: Carboplatin/cisplatin + pemetrexed +/- pembrolizumab
PI: Ian Anderson, MD
Study Coordinator: Tracy Foster // Tracy.Foster@stjoe.org // (707) 521-3836
Resources and Links: clinicaltrials.gov NCT No: NCT03515837

Randomized Phase 2 Trial of AM0010 in Combination with Pembrolizumab vs. Pembrolizumab Alone as First-line Therapy in Patients with Metastatic Non-Small Cell Lung Cancer whose Tumors Have High PD-L1 Expression (CYPRESS 1)

Phase II

This study is designed to compare the efficacy and safety of AM0010 in combination with pembrolizumab versus pembrolizumab alone in patients with treatment-naïve, stage IV/metastatic wild type Non-Small Cell Lung Cancer and tumors with high expression of PD-L1 (> 50%) as measured by objective response rate.

Treatment agent: Pembrolizumab +/- AM0010 (interleukin 10)
PI: Ian Anderson, MD
Study Coordinator: Sabine Ucik // Sabine.Ucik@stjoe.org // (707) 521-3830
Resources and Links: clinicaltrials.gov NCT No: NCT02387216

A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1 (CYPRESS 2)

Phase II

This study is designed to compare the efficacy and safety of AM0010 in combination with nivolumab versus nivolumab alone in patients with stage IV/metastatic wild type Non-Small Cell Lung Cancer and tumors with low tumor expression of PD-L1 (0-49%) as measured by objective response rate.

Treatment agent: Nivolumab +/- AM0010 (interleukin 10)
PI: Ian Anderson, MD
Study Coordinator: Sabine Ucik // Sabine.Ucik@stjoe.org // (707) 521-3830
Resources and Links: clinicaltrials.gov NCT No: NCT03382912

A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants with Resectable Stage IIB or IIIA Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

Phase III

The goal of this study is to evaluate the safety and efficacy of pembrolizumab in combination with platinum doublet neoadjuvant chemotherapy before surgery, followed by pembrolizumab alone after surgery vs. concomitant neoadjuvant platinum doublet chemotherapy plus placebo followed by surgery and adjuvant placebo in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC).

Treatment agent: Platinum doublet chemo +/- pembrolizumab
PI: Ian Anderson, MD
Study Coordinator: Tracy Foster // Tracy.Foster@stjoe.org // (707) 521-3836
Resources and Links: clinicaltrials.gov NCT No: NCT03425643

A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination with Platinum Doublet Chemotherapy and Radiotherapy for Participants with Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799)

Phase II

The purpose of this open-label study is to evaluate the safety and efficacy of pembrolizumab in combination with platinum doublet chemotherapy and standard thoracic radiotherapy in participants with Stage III NSCLC. There are 2 treatment cohorts based on the choice of chemotherapy. Participants with nonsquamous or squamous NSCLC differ in cohort eligibility. The choice of chemotherapy will be determined by the investigator prior to treatment allocation.

Treatment agent: Platinum doublet chemo + radiotherapy + pembrolizumab
PI: Ian Anderson, MD
Study Coordinator: Tracy Foster // Tracy.Foster@stjoe.org // (707) 521-3836
Resources and Links: clinicaltrials.gov NCT No: NCT03631784



Small Cell Lung Cancer

A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared with Topotecan for Subjects with Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) who have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)

Phase III

The purpose of this study is to assess the assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic Small Cell Lung Cancer (SCLC) with high levels of delta-like protein 3 (DLL3) and who have first disease progression during or following front-line platinum-based chemotherapy.

Treatment agent: Topotecan vs rovalpituzumab (DLL3 protein ADC)
PI: Ian Anderson, MD
Study Coordinator: Sabine Ucik // Sabine.Ucik@stjoe.org // (707) 521-3830
Resources and Links: clinicaltrials.gov NCT No: NCT03061812

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)

Phase III

The purpose of this study is to evaluate the efficacy of rovalpituzumab tesirine vs placebo as maintenance therapy following first-line platinum-based chemotherapy.

Treatment agent: Rovalpituzumab (DLL3 protein ADC)
PI: Ian Anderson, MD
Study Coordinator: Sabine Ucik // Sabine.Ucik@stjoe.org // (707) 521-3830
Resources and Links: clinicaltrials.gov NCT No: NCT03033511

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