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
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
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