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Report for Clinical Trial NCT04173507

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Study of Talazoparib Plus Avelumab in Patients With Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer Bearing Pathogenic STK11 Genomic Alterations (LUNG-MAP Sub-Study)

This phase II LUNG-MAP treatment trial studies how well combination treatment (talazoparib plus avelumab) works in treating patients with non-squamous non-small cell lung cancer that has an STK11 gene mutation and has come back (recurrent) or is stage IV. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy drugs given as single therapies or in combination with chemotherapy do not appear to work as well in lung cancer cells with mutations in the STK11 gene versus those that do not have the mutation. Adding the medicine talazoparib to the immunotherapy drug avelumab may work better in treating lung cancers that have an STK11 gene mutation.

NCT04173507 Advanced Lung Non-Squamous Non-Small Cell Carcinoma Recurrent Lung Non-Squamous Non-Small Cell Carcinoma Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8
MeSH:Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Carcinoma Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

Name: Avelumab

Description: Given IV
Type: Drug
Group Labels: 1

Treatment (talazoparib, avelumab)

Name: Talazoparib

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (talazoparib, avelumab)

Name: Talazoparib Tosylate

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (talazoparib, avelumab)


Primary Outcomes

Description: Will be assessed by complete response (CR), unconfirmed CR (UCR), partial response (PR), and unconfirmed PR (UPR).

Measure: Best objective response rate (ORR)

Time: Up to 3 years

Description: Will be defined as a best response of CR, PR, UPR, or UCR by/at the second disease assessment at 12 weeks after registration (+/- 2 weeks), or stable disease at 12 weeks after registration (+/- 2 weeks).

Measure: Disease control rate

Time: At 12 weeks after registration

Secondary Outcomes

Description: Will utilize the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Measure: Frequency and severity of toxicities

Time: Up to 3 years

Description: Binary proportions and associated confidence intervals will be calculated. The method of Kaplan-Meier will be used to estimate survival distributions and the Brookmeyer-Crowley method will be used to estimate confidence intervals around medians.

Measure: Progression free survival

Time: From date of sub-study registration to date of first documentation of progression assessed by local review, central review, symptomatic deterioration, or death due to any cause, assessed up to 3 years

Description: Binary proportions and associated confidence intervals will be calculated. The method of Kaplan-Meier will be used to estimate survival distributions and the Brookmeyer-Crowley method will be used to estimate confidence intervals around medians.

Measure: Overall survival

Time: Up to 3 years

Description: Binary proportions and associated confidence intervals will be calculated. The method of Kaplan-Meier will be used to estimate survival distributions and the Brookmeyer-Crowley method will be used to estimate confidence intervals around medians.

Measure: Duration of response

Time: From date of first documentation of response (CR or PR) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among patients who achieve a response (CR or PR), up to 3 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 S1900C

The method of Kaplan-Meier will be used to estimate survival distributions and the Brookmeyer-Crowley method will be used to estimate confidence intervals around medians.. Inclusion Criteria: - Patients must be assigned to S1900C. --- S1900C ---

Assignment to S1900C is determined by the LUNGMAP protocol genomic profiling using the FoundationOne assay. --- S1900C ---

Biomarker eligibility for S1900C is based on the identification of a pathogenic somatic mutation in STK11 or STK11 bi-allelic loss on tumor - Patients must have histologically or cytologically confirmed stage IV or recurrent non-squamous, mixed squamous/non-squamous (e.g., adeno-squamous carcinoma), or non-small cell lung cancer not otherwise specified (NSCLC NOS). --- S1900C ---

Uncontrolled asthma is defined as a patient having any one of the following criteria: - Poor symptom control: Asthma Control Questionnaire (ACQ) consistently > 1.5 or Asthma Control Test Questionnaire (ACT) < 20 (or "not well controlled" by National Asthma Education and Prevention Program [NAEPP] or Global Initiative for Asthma [GINA] guidelines over the 3 months or evaluation) - Frequent severe exacerbations: 2 or more bursts of systemic corticosteroids (CSs) (> 3 days each) in the previous year - Serious exacerbations: at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous year - Airflow limitation: Forced expiratory volume in 1 second (FEV1) < 80% predicted (in the presence of reduced FEV1/forced vital capacity [FVC] defined as less than the normal lower limit) following a withhold of both short- and long-acting bronchodilators - Patients must not have experienced any immune related adverse event, including pneumonitis that led to permanent discontinuation of prior immunotherapy and/or required prolonged high dose of steroids - Patients must not have evidence of active infection requiring systemic therapy - Patients must not have received any live attenuated vaccinations within 28 days prior to sub-study registration Inclusion Criteria: - Patients must be assigned to S1900C. --- S1900C ---



HPO Nodes


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