Survival Prolongation by Rationale Innovative Genomics

Study summary

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.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAvelumab and Axitinib

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · ALK

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 18, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Worldwide Innovative Network Association

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Worldwide Innovative Network Association
Interventions being studied: Drug: Avelumab; Drug: Axitinib; Drug: Palbociclib

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Biomarkers

EGFR→ALK→ROS1→MET→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

ELIGIBILITY CRITERIA
Age: Men and women aged \>18 years,
Signed written informed consent,
Any histologic type of locally advanced or metastatic NSCLC,
Life expectancy of ≥ 12 weeks,
Measurable or evaluable (cytologically or radiologically detectable disease such as ascites, peritoneal deposits, or lesions which do not fulfill RECIST 1.1 criteria for measurable disease) lesions according to RECIST 1.1 criteria for phase 1 portion. For phase 2, all patients must have RECIST 1.1 measurable disease,
Physiologic function:
Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused),
Hepatic: Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN,
Renal: Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
Pregnancy and contraception:
Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential.
Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 90 days after last treatment administration if the risk of conception exists.
Ability to comply with protocol requirements,
Willingness to consent and ability to undergo a trucut biopsy to obtain a fresh metastasis or primary tumor biopsy, and to undergo bronchoscopy to obtain a biopsy from normal bronchial mucosa,
No serious or medically uncontrolled concomitant conditions that are likely to make the patient unfit for SPRING combination therapy, as per investigator assessment,
ECOG performance status of 0 to 1.

Reasons someone may not be able to joinExclusion criteria

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,
A time period of at least 10 days must have elapsed from last palliative radiotherapy before the first day of treatment on this study,
Specific

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

UCSD Moores Cancer CenterLa Jolla, California
Avera Cancer CenterSioux Falls, South Dakota
Chaim Sheba Medical CenterRamat Gan
Centre Hospitalier LuxembourgLuxembourg
Vall Hebron Institute of OncologyBarcelona

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 18, 2023. Always confirm current availability with the study team.

View original record ↗