Survival Prolongation by Rationale Innovative Genomics

Stopped early · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB

In brief

Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) will receive a tri-therapy associating avelumab, axitinib and palbociclib.

Key facts

Study ID

NCT03386929

Run by

Worldwide Innovative Network Association

People needed

15

Starts

2017-11-29

Expected to finish

2022-12-29

Last updated by the study team

2023-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with documented oncogenic aberrations at enrollment: EGFR, ALK, ROS1 when available, MET exon 14 skipping when available. For squamous undifferentiated cell carcinoma, documentation of these aberrations is not mandatory. Note: For Phase 1 portion, all patients with adenocarcinoma histology must have documentation of results for druggable oncogenic aberrations (EGFR mutations, ALK rearrangements, and ROS1 when available) prior to enrollment on the study.
• For Phase 1 portion, >2 lines of prior therapy in the metastatic setting.
• For the dose escalation phase of the study or until the MTD for the combination regimen has been determined, patients with moderate hepatic impairment defined as AST, ALT, alkaline phosphatase (ALP) >5 times ULN, which would be grade 3 or higher. However, patients with liver metastases with AST/ALT ≤ 5 x ULN can be included in the study.
• For Phase 2 portion, any prior therapy in the metastatic setting.
• Clinical criteria for phase 1 and phase 2 studies:
• Patients with treated brain metastases are eligible as are patients with new, active untreated brain metastasis.
• Participants with a history of myocardial infarction within the last 2 years or with significant cardiac arrhythmias uncontrolled by medication or pacemaker,
• Participants with any history of interstitial lung disease,
• Prior clinically significant toxicities from anticancer agents or radiotherapy which have not regressed to Grade ≤ 1 severity (NCI-CTCAE version 4.03) apart from peripheral neuropathy and alopecia,
• History of any second malignancy in the last two years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease-free for at least two years,
• Autoimmune condition requiring medical intervention,
• Uncontrolled concomitant illness, active infection requiring i.v. antibiotics,
• Patients who have had a thromboembolic event within six months are excluded, as are patients on anticoagulants, except for low dose aspirin (<100 mg/day) and low doses of anticoagulants meant to keep line access open;
• Patients with Grade 3 or 4 (serious) gastrointestinal bleeding within the last six months are excluded.
• Prior > G3 hemoptysis, major blood vessel involvement (specifically including aorta, superior and inferior vena cave, main pulmonary arteries and veins, subclavian arteries and veins and other large blood vessels that in the investigator's opinion places the patients at high risk for major bleeding), and/or central cavitations,
• Known or suspected drug hypersensitivity to any drug used in the combination,
• Difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the oral drugs,
• Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc.) that, in the judgment of the investigator may affect the patient's ability to sign the informed consent and undergo study procedures,
• Taking another experimental drug within 28 days prior to day 1 of the protocol medications in this study,
• Pregnant or breast-feeding women,
• Both male and female patients of reproductive potential must agree to use highly effective contraception, during the study and for 3 months following the last dose of study drug,
• Patients currently taking strong CYP3A4 inducers and inhibitors,
• Patients currently taking proton pump inhibitors due to their impact on the disposition of palbociclib during the phase 1.
• Patients taking other anticancer agents with the exception of denosumab or equivalent medication for bone metastases.
• A time period of at least three weeks (including radiotherapy) or five drug half-lives, whichever is shorter must have elapsed from last non-investigational therapy before first day of treatment on this study,

Where it is running

• UCSD Moores Cancer Center — La Jolla, California, United States
• Avera Cancer Center — Sioux Falls, South Dakota, United States
• Chaim Sheba Medical Center — Ramat Gan, Israel
• Centre Hospitalier Luxembourg — Luxembourg, Luxembourg
• Vall Hebron Institute of Oncology — Barcelona, Spain

Full record on ClinicalTrials.gov

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