Survival Prolongation by Rationale Innovative Genomics (SPRING)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03386929|
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer Stage IIIB||Drug: Avelumab Drug: Axitinib Drug: Palbociclib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Proof of Concept Study to Explore Safety and Efficacy of Tri-therapy Approach in Advanced/Metastatic NSCLC and Retrospectively Assess the Ability of Integrated Genomics and Transcriptomics to Match Patients to the Combination|
|Actual Study Start Date :||November 29, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: Avelumab, Axitinib, Palbociclib
For the Phase 1:
Avelumab is administered intravenously (IV) on Day 1 and Day 15 of each Cycle (one cycle = 28 days) in combination with axitinib po bid and palbociclib po (7 days off; 21 days on).
For the Phase 2:
Avelumab, axitinib and palbociclib are administered at the recommended dose (RP2D) as determined during the phase 1 part of the study.
A human antibody of the immunoglobulin gamma-1 isotype that specifically targets and blocks the Programmed Death ligand (PD-L1) for PD-1.
Other Name: Bavencio
A selective oral (tablet) inhibitor of tyrosine kinases Vascular Endothelial Growth Factor (VEGF) receptors 1, 2, and 3. These receptors are implicated in pathologic angiogenesis, tumor growth and cancer progression.
Other Name: Inlyta
A selective, reversible oral (capsule) inhibitor of cyclin-dependent kinases (CDK) 4 and 6. The inhibition of CDK 4/6 blocks DNA synthesis by prohibiting progression of the cell cycle from G1 to S phase.
Other Name: Ibrance
- Dose Limiting Toxicity (DLT) [ Time Frame: Cycle 1 Days 1-28 (28 days from date of first dose of study treatment) ]DLT is assessed by NCI CTCAE v4.03
- Incidence of the tested 3-Drug Combination Therapy-Emergent Adverse Events and Serious Adverse Events [ Time Frame: From informed consent signature through 90 days after administration of the treatment (last dose) ]The occurrence of adverse events and serious adverse events reported from the signing of an informed consent through 90 days after the last administration of the treatment will be summarized for all subjects who received at least one dose of the study treatment (safety population) and will be evaluated based on NCI CTCAE v4.03: June 14, 2010.
- Response Rate (RR) [ Time Frame: Baseline up to approximately 24 months ]Response rate is defined as the proportion of participants with reduction in tumor burden of a predefined amount based on RECIST 1.1 evaluation
- Duration of the Response [ Time Frame: Baseline up to approximately 24 months ]Duration of Response (DR) is defined for patients with confirmed objective response (Complete Response [CR] or Partial Response [PR]) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
- Progression-Free Survival (PFS) [ Time Frame: Baseline up to approximately 24 months ]Progression Free Survival (PFS) is defined as the time from the first dose of study treatment to the date of disease progression by RECIST 1.1 or death due to any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Baseline up to approximately 24 months ]OS is defined as the time from the first dose of study treatment to the date of death due to any cause.
- SIMS Algorithm to Predict Clinical Outcome [ Time Frame: 4 years ]The proportion of participants whose SIMS analysis matches the treatment combination, will be correlated retrospectively to clinical outcome.
- Incidence of Treatment-related and or Biopsy-related Serious Adverse Events [ Time Frame: 4 years ]The occurrence of treatment-related and or biopsy-related serious adverse events as assessed by NCI CTCAE v4.03 will be summarized for all study subjects.
- Genomic and Transcriptomic Profile [ Time Frame: 4 years ]Genomic (DNA) and transcriptomic (RNA) aberrations (mutations, translocations, rearrangements and changes in expression level) identified in the study population (Non-Small Cell Lung) will be described.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386929
|Contact: FANNY WUNDER, PhDfirstname.lastname@example.org|
|United States, South Dakota|
|Avera Cancer Center||Recruiting|
|Sioux Falls, South Dakota, United States, 57105|
|Contact: Benjamin Solomon, MD 605-322-7049 email@example.com|
|Principal Investigator:||RAZELLE KURZROCK, MD||University of California, San Diego|