Ignite Creation Date:
2024-05-06 @ 1:57 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04173507
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2019-11-20
Brief Title:
Combination Treatment Talazoparib Plus Avelumab for Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer With STK11 Gene Mutation A LUNG-MAP Treatment Trial
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 bodys 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
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the objective response rate ORR confirmed and unconfirmed complete and partial with talazoparib plus avelumab in patients with stage IV or recurrent non-squamous non-small cell lung cancer bearing pathogenic STK11 genomic alterations that were previously-treated with anti-PD-1PD-L1 therapy and platinum-based chemotherapy
II To evaluate disease control rate at 12 weeks DCR12 after registration
SECONDARY OBJECTIVES
I To evaluate investigator assessed progression-free survival IA-PFS II To evaluate overall survival OS III To evaluate duration of response DOR among responders IV To evaluate the frequency and severity of toxicities
TRANSLATIONAL MEDICINE OBJECTIVES
I To collect process and bank cell-free deoxyribonucleic acid DNA cfDNA at baseline cycle 3 day 1 progression and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA ctDNA and examine molecular mechanisms of resistance to talazoparib and avelumab
II To establish a tissueblood repository from patients with refractory non-small cell lung cancer NSCLC
III To evaluate clinical outcomes ORR IA-PFS OS in patients with concurrent somatic mutations in KEAP1 detected on the Foundation Medicine Inc FMI panel from the LUNGMAP screening protocol
IV To evaluate clinical outcomes ORR IA-PFS OS in patients with concurrent mutations in ATM or other DNA damage response genes detected on the FMI panel from the LUNGMAP screening protocol
V To evaluate the association between tumor mutational burden TMB measured on the FMI panel from the LUNGMAP screening protocol and clinical outcomes ORR IA-PFS OS
OUTLINE
Patients receive talazoparib orally PO daily and avelumab intravenously IV over 60 minutes on days 1 and 15 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up until death or 3 years after sub-study registration
I To evaluate the objective response rate ORR confirmed and unconfirmed complete and partial with talazoparib plus avelumab in patients with stage IV or recurrent non-squamous non-small cell lung cancer bearing pathogenic STK11 genomic alterations that were previously-treated with anti-PD-1PD-L1 therapy and platinum-based chemotherapy
II To evaluate disease control rate at 12 weeks DCR12 after registration
SECONDARY OBJECTIVES
I To evaluate investigator assessed progression-free survival IA-PFS II To evaluate overall survival OS III To evaluate duration of response DOR among responders IV To evaluate the frequency and severity of toxicities
TRANSLATIONAL MEDICINE OBJECTIVES
I To collect process and bank cell-free deoxyribonucleic acid DNA cfDNA at baseline cycle 3 day 1 progression and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA ctDNA and examine molecular mechanisms of resistance to talazoparib and avelumab
II To establish a tissueblood repository from patients with refractory non-small cell lung cancer NSCLC
III To evaluate clinical outcomes ORR IA-PFS OS in patients with concurrent somatic mutations in KEAP1 detected on the Foundation Medicine Inc FMI panel from the LUNGMAP screening protocol
IV To evaluate clinical outcomes ORR IA-PFS OS in patients with concurrent mutations in ATM or other DNA damage response genes detected on the FMI panel from the LUNGMAP screening protocol
V To evaluate the association between tumor mutational burden TMB measured on the FMI panel from the LUNGMAP screening protocol and clinical outcomes ORR IA-PFS OS
OUTLINE
Patients receive talazoparib orally PO daily and avelumab intravenously IV over 60 minutes on days 1 and 15 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up until death or 3 years after sub-study registration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2019-07142 | REGISTRY | None | None |
| S1900C | OTHER | None | None |
| S1900C | OTHER | None | None |
| U10CA180888 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180888 |