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Non-Small Cell Lung CancerPhase 2KEAPSAKENCT04265534

KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC

A Phase 2 study testing Telaglenastat, Carboplatin Chemotherapy and Pemetrexed Chemotherapy in people with Non-Small Cell Lung Cancer and Non-squamous Non-small-cell Lung Cancer, run by Calithera Biosciences, Inc at 102 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a Phase 2, randomized, multicenter, double-blind study of the glutaminase inhibitor telaglenastat with standard-of-care pembrolizumab and chemotherapy versus placebo with standard-of-care pembrolizumab and chemotherapy for first line treatment of metastatic disease in patients with KEAP1/NRF2-mutated, stage… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telaglenastat, Carboplatin Chemotherapy and Pemetrexed Chemotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
102 sitesUnited States
Study dates
24 Jul 2020to 9 Feb 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically documented non-squamous NSCLC
  • Stage IV (M1a-c, AJCC 8th Edition, Amin 2017) disease not previously treated with systemic therapy for metastatic NSCLC
  • Patients who received adjuvant or neo-adjuvant therapy (with or without immunotherapy) for localized NSCLC are eligible if all adjuvant/neo-adjuvant therapy (including immunotherapy) was completed at least 6 months prior to the development of metastatic disease.
  • No known actionable mutation in EGFR, ALK, ROS1, BRAF, NTRK or other known actionable mutation for which there is approved therapy in the first-line lung cancer setting
  • 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 computed 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
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  • Age ≥ 18 years on the day of signing informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Estimated life expectancy of at least 3 months
  • Recovery to baseline or ≤ grade 1 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from toxicities related to the prior treatment, unless after discussion with the medical monitor, the AE(s) are deemed clinically non-significant and/or stable on supportive therapy
  • Has sponsor-approved eligible mutation in KEAP1 or NRF2 documented by NGS from a CAP-accredited and/or CLIA-certified laboratory (study-provided NGS or other NGS) and STK11 mutation status is known for the purpose of stratification.
  • Adequate organ function laboratory findings (defined per protocol)
  • Reproductive status:
  • A female patient of childbearing potential must: i. Have a negative serum pregnancy test within 7 days prior to randomization ii. Agree to use methods of contraception outlined in Section 8.1.2 during the study through 120 days following the last dose of telaglenastat or pembrolizumab, or through 180 days following the last dose of chemotherapeutic drugs iii. Postmenopausal females (no menses for > 1 year without an alternate medical cause) and surgically sterilized females are exempt from these requirements b. Male patients who are sexually active with heterosexual partners of childbearing potential must agree to contraceptive requirements outlined in Section 8.1.2 and refrain from donating sperm during the study through 120 days following the last dose of telaglenastat or pembrolizumab, or through 180 days following the last dose of chemotherapeutic drugs

Who cannot join

  • Squamous cell histology and mixed histology tumors with any small-cell/neuroendocrine component (other mixed histology should be reviewed with the medical monitor for eligibility)
  • Any other concurrent malignancy requiring local or systemic therapy. Patients with other previously treated malignancy(ies) are allowed if the specific neoplasm, in the opinion of the principal investigator and with the agreement of the medical monitor, is not expected to interfere with study-specific endpoints
  • Radiation therapy to the lung > 30 Gy within 6 months prior to randomization
  • Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal carcinomatosis
  • Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
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  • Treatment with chronic systemic steroids greater than 10 mg equivalent of prednisone per day
  • Unstable/inadequate cardiac function, defined as the following:
  • Myocardial infarction or symptomatic ischemia within 6 months prior to randomization
  • Uncontrolled or clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on anti-arrhythmics are excluded; patients with 1st degree atrioventricular [AV] block or asymptomatic left anterior fascicular block [LAFB]/right bundle branch block [RBBB] are eligible)
  • Congestive heart failure (New York Heart Association class III to IV)
  • Unable to swallow oral medications
  • Known sensitivity to any component of the study treatment (pembrolizumab, carboplatin, pemetrexed, and/or telaglenastat) or previous severe hypersensitivity to another monoclonal antibody (mAb)
  • Unable or unwilling to take folic acid or vitamin B12 supplementation (per pemetrexed label)
  • Unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) as specified in pemetrexed label
  • Interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoid treatment
  • Unable or unwilling to discontinue proton pump inhibitor (PPI) use ≥ 5 days prior to randomization
  • Patient known to be positive for Human Immunodeficiency Virus (HIV)
  • Known active Hepatitis B or C. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive Hepatitis C antibody result and known quantitative Hepatitis C virus RNA results greater than the lower limits of detection of the assay. Patients receiving antiviral therapy for Hepatitis B or C also are not eligible
  • 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
  • Regular use of illicit drugs or history (within past year) of substance abuse (including alcohol)
  • Patients who are pregnant or lactating
  • Major surgery < 3 weeks prior to randomization. In addition, patients with ongoing clinically relevant complications from prior surgery are not eligible and they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
  • Any radiation therapy within 2 weeks prior to randomization (with exception of SRS for brain metastases). In addition, patients with ongoing clinically relevant complications from prior radiation therapy, patients requiring corticosteroids to treat radiation toxicity and patients who developed radiation pneumonitis are not eligible.
  • Symptomatic ascites or pleural effusion. 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 or oral study drug
  • Infection requiring more than 5 days of parenteral antibiotics, antivirals, or antifungals within two weeks prior to randomization. Anti-infective therapy must be completed at least 7 days before randomization
  • Patients with active and/or untreated central nervous system metastasis including carcinomatous meningitis (leptomeningeal disease) are not eligible. Patients with previously treated brain metastases are eligible if they meet the following criteria:
  • Received definitive treatment with stereotactic radiosurgery (SRS) or surgery to all known central nervous system (CNS) lesions (whole brain radiotherapy is not an eligible modality)
  • Be at least 4 weeks post-surgical resection of CNS disease, symptomatically stable and off steroids before randomization
  • Any live-virus vaccination within 28 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist ®) are live attenuated vaccines and are not allowed
  • Has had an allogeneic tissue/solid organ transplant

Trial locations and contacts

102 sites in 1 country.

102 sites in 1 country

United States102 sites

  • New York Oncology Hematology, P.C. (400 Patoon Creek Blvd.)

    Albany, New York, 12206

  • New York Oncology Hematology, P.C. (43 New Scotland Ave.)

    Albany, New York, 12208

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131

  • University Cancer and Blood Center

    Athens, Georgia, 30607

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Texas Oncology - Austin Midtown

    Austin, Texas, 78705

  • Texas Oncology - Austin Central

    Austin, Texas, 78731

  • Texas Oncology - South Austin

    Austin, Texas, 78745

  • Johns Hopkins Bayview Memorial Hospital

    Baltimore, Maryland, 21224

  • Texas Oncology Beaumont - USOR

    Beaumont, Texas, 77701

  • New Jersey Cancer Care and Blood Disorders (NJCCBD)

    Belleville, New Jersey, 07109

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07932

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Oncology and Hematology Associates of Southwest Virginia

    Blacksburg, Virginia, 24060

  • Boca Raton Regional Hospital Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Central Care Cancer Center

    Bolivar, Missouri, 65613

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

  • Cone Health at Alamance Regional

    Burlington, North Carolina, 27215

  • Aultman Hospital

    Canton, Ohio, 44710

  • Tennessee Oncology - Chattanooga (SCRI)

    Chattanooga, Tennessee, 37404

  • TriHealth Cancer Institute

    Cincinnati, Ohio, 45220

  • New York Oncology Hematology, P.C.

    Clifton Park, New York, 12065

  • Maryland Oncology Hematology - USOR

    Columbia, Maryland, 21044

  • Ohio State University, James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

  • Ohio Health

    Columbus, Ohio, 43214

  • Minnesota Oncology Hematology, P.A.

    Coon Rapids, Minnesota, 55433

  • Pontchartrain Cancer Center

    Covington, Louisiana, 70443

  • Texas Oncology - Denison

    Denison, Texas, 75020

  • Henry Ford Cancer Institute

    Detroit, Michigan, 48202

  • Minnesota Oncology Hematology, P.A.

    Edina, Minnesota, 55435

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Holy Cross Hospital - Bines Cancer Center

    Fort Lauderdale, Florida, 33308

  • Florida Cancer Specialist - South (SCRI)

    Fort Myers, Florida, 33901

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Compassionate Cancer Care

    Fountain Valley, California, 92708

  • Frederick Health - James M. Stockman Cancer Institute

    Frederick, Maryland, 21702

  • St. Joseph Heritage Healthcare

    Fullerton, California, 92835

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Memorial Cancer Institute at Memorial Hospital West

    Hollywood, Florida, 33021

  • Hawaii Cancer Care

    Honolulu, Hawaii, 96813

  • Oncology Consultants

    Houston, Texas, 770390

  • Bronson Methodist Hospital (West Michigan Cancer Center)

    Kalamazoo, Michigan, 49001

  • Oncology and Hematology of South Texas

    Laredo, Texas, 78041

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • Loma Linda University Medical Center

    Loma Linda, California, 92350

  • University of Southern California (USC)

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA

    Los Angeles, California, 90095

  • Oncology and Hematology Associates of Southwest Virginia

    Low Moor, Virginia, 24457

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53705

  • Minnesota Oncology Hematology, P.A.

    Maplewood, Minnesota, 55109

  • Northwest Georgia Oncology

    Marietta, Georgia, 30060

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Froedtert Hospital and the Medical College of Wisconsin (MCW)

    Milwaukee, Wisconsin, 53226

  • Pelmutter Cancer Center at Winthrop

    Mineola, New York, 11501

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • University of South Alabama - Mitchell Cancer Center

    Mobile, Alabama, 36604

  • Tennessee Oncology - Nashville (SCRI)

    Nashville, Tennessee, 37203

  • New York University Langone (NYU)

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York, 10065

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • University of California Irvine, Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • The Valley Hospital - Luckow Pavilion

    Paramus, New Jersey, 07652

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center

    Portland, Oregon, 92713

  • Oregon Health & Science University (OHSU) Knight Cancer Institute

    Portland, Oregon, 97239

  • Virginia Commonwealth University (VCU) Massey Cancer Center

    Richmond, Virginia, 23298

  • Oncology and Hematology Associates of Southwest Virginia

    Roanoke, Virginia, 24014

  • Oncology of Northshore

    Rolling Meadows, Illinois, 60008

  • Minnesota Oncology Hematology, P.A.

    Saint Paul, Minnesota, 55102

  • Oncology and Hematology Associates of Southwest Virginia

    Salem, Virginia, 24153

  • Utah Cancer Specialist

    Salt Lake City, Utah, 84106

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • St. Joseph Heritage Healthcare - Santa Rosa

    Santa Rosa, California, 95403

  • University of Washington Seattle Cancer Care Alliance (SCCA)

    Seattle, Washington, 98109

  • Sanford Health

    Sioux Falls, South Dakota, 57104

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077

  • Beacon Health

    South Bend, Indiana, 46601

  • Washington University

    St Louis, Missouri, 63110

  • Florida Cancer Specialist - North (SCRI)

    St. Petersburg, Florida, 33705

  • Pennsylvania State University Milton S. Hershey Medical Center

    State College, Pennsylvania, 16801

  • Northwest Medical Specialities

    Tacoma, Washington, 98405

  • Florida Cancer Specialist - Panhandle (SCRI)

    Tallahassee, Florida, 32308

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623

  • Oklahoma Cancer Specialists and Research Institute (OCSRI)

    Tulsa, Oklahoma, 74146

  • Johns Hopkins Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Florida Cancer Specialist - East (SCRI)

    West Palm Beach, Florida, 33401

  • University of Kansas Medical Center (KUMC)

    Westwood, Kansas, 66205

  • Minnesota Oncology Hematology, P.A.

    Woodbury, Minnesota, 55125

  • Oncology and Hematology Associates of Southwest Virginia

    Wytheville, Virginia, 24382

  • St. Joseph Mercy Hospital Cancer Care Center

    Ypsilanti, Michigan, 48197

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

Other trials in United States

About this study

Official title: A Phase 2 Randomized, Multicenter, Double-Blind Study of the Glutaminase Inhibitor Telaglenastat With Pembrolizumab and Chemotherapy Versus Placebo With Pembrolizumab and Chemotherapy in First-Line, Metastatic KEAP1/NRF2-Mutated, Nonsquamous, Non-Small Cell Lung Cancer (NSCLC)

This is a Phase 2, randomized, multicenter, double-blind study of the glutaminase inhibitor telaglenastat with standard-of-care pembrolizumab and chemotherapy versus placebo with standard-of-care pembrolizumab and chemotherapy for first line treatment of metastatic disease in patients with KEAP1/NRF2-mutated, stage IV, nonsquamous, non-small cell lung cancer (NSCLC). The study primary endpoints are PFS per RECIST v. 1.1 and safety. KEAP1/NRF2 mutation status (for eligibility) and STK11/LKB1 status (for stratification) will be determined by next generation sequencing. A commercial liquid biopsy (circulating tumor DNA) NGS test will be provided to study participants free of charge.

Being tested
Telaglenastat, Carboplatin Chemotherapy, Pemetrexed Chemotherapy, Pembrolizumab Immunotherapy, Placebo
Keywords
NSCLC, KEAP1, NRF2, NFE2l2, LKB1, STK11, Next Generation Sequencing, NGS, Mutation, Pembrolizumab, Pemetrexed, Carboplatin, Randomized, Placebo, Chemotherapy, Targeted Therapy, Telaglenastat, Glutamine, Glutaminase, Glutathione
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelaglenastatDrug

    Also called CB-839

    Oral Glutaminase Inhibitor

  • Carboplatin ChemotherapyDrug

    Also called Paraplatin

    IV infusion

  • Pemetrexed ChemotherapyDrug

    Also called Alimta

    IV infusion

  • Pembrolizumab ImmunotherapyBiological

    Also called Keytruda

    IV infusion

  • PlaceboDrug

    Also called Oral placebo

    Oral placebo

  • Folic acid 400 -1000 μgDietary supplement

    Orally, once daily beginning 7 days prior to the first dose of pemetrexed and continue until 21 days after the last dose of pemetrexed.

  • Vitamin B12 1000 μgDietary supplement

    Vitamin B12 1000 μg Intramuscular injection one week prior to the first dose of pemetrexed and once every 3 cycles (9 weeks) thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.

  • Dexamethasone 4 mgDrug

    For prophylaxis, orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.

Study groups in NCT04265534
Study groupRoleWhat they receive
Telaglenastat with Pembrolizumab and ChemotherapyExperimentalThe glutaminase inhibitor telaglenastat will be administered orally, twice daily with food, every day in combination with standard-of-care pembrolizumab plus chemotherapy by intravenous (IV) infusion every 3 weeks.
Receives: Drug: Telaglenastat; Drug: Carboplatin Chemotherapy; Drug: Pemetrexed Chemotherapy; Biological: Pembrolizumab Immunotherapy; Dietary Supplement: Folic acid 400 -1000 μg; Dietary Supplement: Vitamin B12 1000 μg; Drug: Dexamethasone 4 mg
Placebo with Pembrolizumab and ChemotherapyPlacebo comparatorPlacebo will be administered orally twice daily with food every day in combination with standard-of-care pembrolizumab plus chemotherapy by IV infusion every 3 weeks.
Receives: Drug: Carboplatin Chemotherapy; Drug: Pemetrexed Chemotherapy; Biological: Pembrolizumab Immunotherapy; Drug: Placebo; Dietary Supplement: Folic acid 400 -1000 μg; Dietary Supplement: Vitamin B12 1000 μg; Drug: Dexamethasone 4 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS), Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Duration of investigator-determined PFS per RECIST v1.1 in the intent-to-treat (ITT) population

    Measured: Up to 24 months

  2. Safety and Tolerability of Telaglenastat Plus Standard-of-Care Pembrolizumab and Chemotherapy Assessed by Type, Incidence, Severity, Seriousness, and Study Drug Relatedness of Adverse Events per CTCAE v5.0

    Measured: Up to 55 months

  3. Recommended Phase 2 Dose of Telaglenastat in Combination with Standard-of-Care Pembrolizumab and Chemotherapy Assessed by Incidence and Nature of Protocol Defined Dose-Limiting Toxicities (DLTs) During the Safety Run-in Period

    Measured: Up to 6 months

Secondary outcomes (7)

  1. Objective Response Rate (ORR) for Patients Treated with Telaglenastat plus Standard-of-Care Pembrolizumab and Chemotherapy versus Placebo plus Standard-of-Care Pembrolizumab and Chemotherapy

    ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RECIST v1.1 criteria as assessed by the investigator.

    Measured: Up to 24 months

  2. Duration of Response (DOR) for Patients Treated with Telaglenastat plus Standard-of-Care Pembrolizumab and Chemotherapy versus Placebo plus Standard-of-Care Pembrolizumab and Chemotherapy

    DOR is defined as the duration of response for patients achieving a CR or PR

    Measured: Up to 24 months

  3. Overall Survival

    Measured: Up to 55 months

  4. PFS in the Subgroup of Patients with Biochemical Evidence of Activation of the NRF2 Pathway

    Measured: Up to 24 months

  5. ORR in the Subgroup of Patients with Biochemical Evidence of Activation of the NRF2 Pathway

    Measured: Up to 24 months

  6. DOR in the Subgroup of Patients with Biochemical Evidence of Activation of the NRF2 Pathway

    Measured: Up to 24 months

  7. OS in the Subgroup of Patients with Biochemical Evidence of Activation of the NRF2 Pathway

    Measured: Up to 55 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start24 Jul 2020
  3. Primary completion5 Nov 2021
  4. Study completion9 Feb 2022

Why it stopped: Lack of Clinical Benefit

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04265534
Sponsor's protocol ID
CX-839-014
Acronym
KEAPSAKE
Status last verified
Sep 2022
First submitted
7 Feb 2020
Last updated
21 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27.

    PubMed 39462179

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telaglenastat, Carboplatin Chemotherapy and Pemetrexed Chemotherapy in people with Non-Small Cell Lung Cancer and Non-squamous Non-small-cell Lung Cancer, run by Calithera Biosciences, Inc at 102 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of Clinical Benefit). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS), Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04265534, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.

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