Lung Cancer Clinical Trial

A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer

Summary

This is a multicenter, randomized, open-label Phase 2 study of sapanisertib in biomarker-defined populations of sqNSCLC. Patients with NFE2L2 (the name for gene encoding the protein called NRF2)-mutated or wild-type sqNSCLC should have disease that has progressed on or after at least two prior systemic therapies for metastatic disease including platinum-doublet chemotherapy and a programmed cell death 1 ligand 1 (PD-L1) inhibitor. The study will evaluate sapanisertib monotherapy in patients with relapsed/refractory sqNSCLC as two separate groups: Group A: NFE2L2-mutated sqNSCLC and Group B: NFE2L2-WT sqNSCLC.

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Full Description

NFE2L2 mutation status for all patients will be identified using local or central next generation sequencing (NGS) testing on archival or fresh tissue or circulating tumor deoxyribonucleic acid (ctDNA), the results of which must be reviewed and approved by the Sponsor prior to enrollment. Each group will be randomized 1:1 to one of two doses/schedules of sapanisertib. Approximately 30 NFE2L2-mutant and 20 NFE2L2-wild type patients will be enrolled. Patients will be treated with sapanisertib until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), unacceptable toxicity, withdrawal of consent, or death.

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Eligibility Criteria

Inclusion Criteria:

Stage IV squamous NSCLC.
Disease progression during or after prior systemic therapy for metastatic disease, which must include platinum-doublet chemotherapy and immune checkpoint inhibitor therapy (anti-PD-(L)1 +/-anti-CTLA-4), if approved and available, administered as separate lines of therapy or in combination.
Has study-eligible mutation in NFE2L2 or wild-type NFE2L2 using NGS from a College of American Pathologists- (CAP)-accredited and/or a Clinical Laboratory Improvement Amendments- (CLIA)-certified laboratory
Must have at least one radiographically measurable lesion per RECIST v1.1 defined as a lesion that is ≥ 10 mm in longest diameter or lymph node that is ≥ 15 mm in short axis imaged by computerized tomography (CT) scan or Magnetic Resonance Imaging (MRI).
Target lesions situated in a previously irradiated area may be considered measurable if progression has been demonstrated subsequent to radiation therapy.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Adequate Organ Function Laboratory Findings: Absolute neutrophil count (ANC): ≥1,500/mm3, Hemoglobin: ≥9.0 g/dL * Transfusions and growth factors must not be used within 2 weeks prior to randomization to meet these requirements, Platelets: ≥ 100,000/mm3, Calculated creatinine clearance (CrCl): ≥ 40mL/min, Serum total bilirubin: ≤ 1.5× upper limit of normal (ULN) OR ≤ 3 mg/dL for patients with Gilbert's disease, AST (SGOT) and ALT (SGPT): ≤ 2.5× ULN OR ≤ 5× ULN for patients with liver metastases, Fasting triglycerides: < 300 mg/dL, Fasting serum glucose: <160 mgdL

A female patient of childbearing potential must:

Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study treatment
Agree to use acceptable methods of contraception(See Section 8.1.2) during the study and for a minimum of 14 days following the last dose of sapanisertib
Post-menopausal females (no menses for >1 year without an alternative medical cause) and surgically sterilized females are exempt from these requirements.
Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential and refrain from donating sperm during the study and for a minimum of 14 days following the last dose of sapanisertib.

Exclusion Criteria:

Non-squamous cell histology and mixed histology tumors with any small-cell/neuroendocrine component.
Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment per investigator's discretion.

Receipt before the first dose of study drug of any of the following:

i. Any investigational agent within 4 weeks. ii. Chemotherapy with 3 weeks (6 weeks for nitrosoureas or mitomycin C) iii. Any radiotherapy within 2 weeks prior to randomization with the exception of palliative radiotherapy for isolated tumor lesions

Major surgery or other anticancer therapy not previously specified within 4 weeks.
Unable or unwilling to discontinue proton pump inhibitor (PPI) use ≥ 5 days prior to randomization.
Interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoid treatment.
Any condition including social, psychiatric or medical (including uncontrolled significant concurrent illness) that in the opinion of the Investigator could interfere with treatment or protocol-related procedures.
Patients who are pregnant or lactating.
Symptomatic ascites or pleural effusion. Exception: Patients who are clinically stable following treatment for these conditions (including therapeutic thoraco-or paracentesis) are eligible.
Refractory nausea and vomiting, uncontrolled diarrhea, malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes or other situation that may preclude adequate absorption of oral study medication.
Infection requiring more than 5 days of parenteral antibiotics, antivirals, or antifungals within two weeks prior to randomization.
Patients receiving systemic corticosteroids greater than prednisone 10 mg or equivalent (excluding inhalers or low-dose hormone replacement therapy) within the 7 days before treatment initiation.
Previous intolerance to mammalian target of rapamycin (mTOR), AKT, or dual PI3K/mTOR inhibitors.
Patients with symptomatic, active/untreated central nervous system metastasis and/or leptomeningeal disease are not eligible.
Significant active cardiovascular disease
Participants who are known to be HIV-positive, unless assessed to be healthy with a low risk of AIDS-related outcomes.
Known active Hepatitis B or C infection.
Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of the study drug.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT05275673

Recruitment Status:

Recruiting

Sponsor:

Calithera Biosciences, Inc

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There are 14 Locations for this study

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UC Davis Comprehensive Cancer Center
Davis California, 95817, United States More Info
Nicole Terry
Contact
916-734-4913
[email protected]
Providence Medical Group Santa Rosa - Cancer Center
Santa Rosa California, 95403, United States More Info
Teresa Lund
Contact
707-521-3803
[email protected]
Tracy Foster
Contact
[email protected]
Ian C Anderson, MD
Principal Investigator
Florida Cancer Specialists
Fort Myers Florida, 33901, United States More Info
Lowell Hart, MD
Contact
[email protected]
Lowell Hart, MD
Principal Investigator
Ocala Oncology Center
Ocala Florida, 34474, United States More Info
Sanjit Nirmalanandhan
Contact
352-732-4032
[email protected]
Rama Balaraman, MD
Principal Investigator
Florida Cancer Specialists
Tallahassee Florida, 32308, United States More Info
Augusto Villegas, MD
Contact
[email protected]
Augusto Villegas, MD
Principal Investigator
Norton Cancer Institute, Downtown
Louisville Kentucky, 40202, United States More Info
John Hamm, MD
Contact
502-629-2500
[email protected]
John Hamm, MD
Principal Investigator
Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Hirva Mamdani, MD
Contact
313-576-8711
[email protected]
Hirva Mamdani, MD
Principal Investigator
Washington University - Patient Care Coordinator Center
Saint Louis Missouri, 63110, United States More Info
Memorial Sloan Kettering Cancer Center - Thoracic
New York New York, 10065, United States More Info
Paul Paik, MD
Contact
646-888-4202
[email protected]
Paul Paik, MD
Principal Investigator
Zangmeister Cancer Center
Columbus Ohio, 43219, United States More Info
Nancy Zangmeister
Contact
614-383-6236
[email protected]
Jorge Rios, MD
Principal Investigator
Providence Cancer Institute Franz Clinic
Portland Oregon, 97213, United States More Info
Julie Cramer, MA
Contact
412-952-5634
[email protected]
Rachel Sanborn, MD
Principal Investigator
UPMC Cancer Pavilion
Pittsburgh Pennsylvania, 15232, United States More Info
Jennifer Ruth
Contact
412-623-8963
[email protected]
Taofeek Owonikoko, MD
Principal Investigator
Tennessee Oncology
Nashville Tennessee, 37203, United States More Info
Kelly Goddard, RN
Contact
[email protected]
Melissa Johnson, MD
Principal Investigator
Virginia Cancer Specialist, PC
Fairfax Virginia, 22031, United States More Info
Carrie Friedman, RN
Contact
703-636-1473
[email protected]
Alexander Spira, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT05275673

Recruitment Status:

Recruiting

Sponsor:


Calithera Biosciences, Inc

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