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

STATUS

Recruiting
participants needed

120
sponsor

Calithera Biosciences, Inc

Send

Updated on 19 February 2024

See if I qualify

folic acid

measurable disease

metastasis

carboplatin

pembrolizumab

pemetrexed

stage iv non-small cell lung cancer

systemic therapy

adjuvant therapy

ros1

liquid biopsy

proto-oncogene tyrosine-protein kinase ros

adjuvant

BRAF

EGFR

NTRK

vitamin b12 level

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 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.

Details

Condition	Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Non-Squamous Non-Small Cell Neoplasm of Lung, KEAP1 Gene Mutation, NRF2 Gene Mutation, NFE2L2 Gene Mutation
Age	18years - 100years
Treatment	Placebo, Telaglenastat, Carboplatin Chemotherapy, Pemetrexed Chemotherapy, Pembrolizumab Immunotherapy, Folic acid 400 -1000 μg, Vitamin B12 1000 μg, Dexamethasone 4 mg
Clinical Study Identifier	NCT04265534
Sponsor	Calithera Biosciences, Inc
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	b'Histologically or cytologically documented nonsquamous NSCLC'
	b'Stage IV (M1a-c, AJCC 8th Edition) disease not previously treated with systemic'
	b'therapy for metastatic NSCLC'
	b'a. Patients who received adjuvant or neoadjuvant therapy (with or without'
	b'immunotherapy) for localized NSCLC are eligible if all adjuvant/neoadjuvant therapy'
	b'(including immunotherapy) was completed at least 6 months prior to the development of'
	b'metastatic disease.'
	b'No known actionable mutation in EGFR, ALK, ROS1, BRAF, NTRK or other known actionable'
	b'mutation for which there is approved therapy.'
	b'Measurable disease per RECIST 1.1.'
	b'Life expectancy of at least 3 months.'
	b'Mutation in KEAP1 or NRF2 documented by NGS from a CAP-accredited and/or'
	b'CLIA-certified laboratory and STK11/LKB1 mutation status is known for the purpose of'
	b'tratification.'
	b'Adequate hepatic, renal, cardiac and hematologic function.'
	b'Willingness to use adequate contraception as defined in the study protocol'
Exclusion Criteria
	b'Squamous cell histology and mixed histology tumors with any small-cell component'
	b'(other mixed histology and large cell neuroendocrine histology is allowed).'
	b'Known history of malignancy within the past three years except for adequately treated'
	b'basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or other'
	b'neoplasm that, in the opinion of the principal investigator and with the agreement of'
	b'the medical monitor, will not interfere with study-specific endpoints.'
	b'Had radiation therapy to the lung > 30 Gy within 6 months prior to randomization.'
	b'Has active autoimmune disease that has required systemic treatment in past 2 years.'
	b'Is currently receiving chronic systemic steroids and/or immunosuppressive drugs.'
	b'Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs),'
	b'other than an aspirin dose \\u22641.3 g per day, for a 5-day period (8-day period for'
	b'long-acting agents, such as piroxicam).'
	b'Unable to swallow oral medications.'
	b'Previously had a severe hypersensitivity reaction to treatment with another monoclonal'
	b'antibody (mAb).'
	b'Known positivity for Hepatitis B or C.'
	b'Is unable or unwilling to take folic acid or vitamin B12 supplementation.'
	b'Interstitial lung disease or a history of pneumonitis that required oral or'
	b'intravenous glucocorticoid treatment.'
	b'Unable or unwilling to discontinue proton pump inhibitors (PPI) at least 5 days before'
	b'randomization.'
	b'Major surgery within 3 weeks of randomization.'
	b'Symptomatic ascites or pleural effusion.'
	b'Any condition that may preclude adequate absorption of oral study drug.'
	b'Patients with active and/or untreated central nervous system metastasis including'
	b'carcinomatous meningitis (leptomeningeal disease) are not eligible. Patients with'
	b'previously treated brain metastases are eligible if they meet the following criteria:'
	b'Received definitive treatment with stereotactic radiosurgery (SRS) or surgery to'
	b'all known central nervous system (CNS) lesions (whole brain radiotherapy is not'
	b'an eligible modality)'
	b'Are at least 7 days post SRS and 4 weeks post-surgical resection of CNS disease,'
	b'ymptomatically stable and off steroids before randomization'

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

stage iv non-small cell lung cancer

proto-oncogene tyrosine-protein kinase ros

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

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