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.
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-1/PD-L1 therapy and platinum-based chemotherapy.
II. To evaluate disease control rate at 12 weeks (DCR12) after registration.
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 tissue/blood repository from patients with refractory non-small cell lung
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
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
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).
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
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.
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.