SWOG clinical trial number
S1400G

A PHASE II STUDY OF TALAZOPARIB FOR PREVIOUSLY TREATED HOMOLOGOUS RECOMBINATION REPAIR DEFICIENCY POSITIVE PATIENTS WITH STAGE IV SQUAMOUS CELL LUNG CANCER (LUNG-MAP SUB-STUDY)

Closed
Phase
Accrual
85%
Abbreviated Title
Lung-MAP S1400G: HRRD - Talazoparib (BMN 673)
Status Notes
Effective July 23, 2018, S1400G will be permanently closed to accrual.

Effective 2:00 p.m. Pacific Time on June 20th, 2018, S1400G will be temporarily closed to accrual.

Effective 2:00 p.m. Pacific Time on February 7, 2017, S1400G will be open for patient accrual.


This is a potential FDA registration study. There will be additional centralized and on-site monitoring conducted in addition to routine audits. Sites must also maintain a study specific Trial Master File for this study (https://swog.org/Visitors/QA/Index.asp).
Activated
02/07/2017
Closed
07/23/2018
Participants
NCORP, Members, Medical Oncologists, Pathologists, CTSU, Affiliates, CCTG

Research committees

Lung Cancer

Treatment

Talazoparib

Other Study Materials

Eligibility Criteria Expand/Collapse

(In addition to S1400 Lung-MAP common criteria)

Sub-Study Specific Disease Related Criteria

a. Patients must be assigned to S1400G. S1400G biomarker eligibility defined as Homologous Recombination Repair Deficiency (HRRD) Positive.


b. Patients must not have had prior exposure to any agent with a PARP inhibitor (e.g., veliparib, olaparib, rucaparib, niraparib, talazoparib [BMN 673]) as its primary pharmacology. For information and a list of PARP inhibitors, please consult the S1400G � Poly Polymerase Inhibitors, Scott et al., 2015 JCO ref from the link on the S1400G protocol abstract page of the SWOG (http://swog.org) or CTSU (https://www.ctsu.org) websites.

c. Patients must have achieved stable disease, a partial response, or a complete response at their first disease assessment after initiating first-line platinum-based chemotherapy. Patients determined to have progressed (in the opinion of the treating physician) at their first disease assessment are not eligible.

Sub-Study Specific Clinical/Laboratory Criteria

a. Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of talazoparib (BMN 673) (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or active peptic ulcer disease). Patients must not have active small or large intestine inflammation such as Crohn's disease or ulcerative colitis (within 12 months of sub-study registration).

b. Patients must be able to take oral medications. Patients must be able to swallow capsules whole without crushing or altering them in any way.

c. Patients must not be taking, nor plan to take while on protocol treatment strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors (see Section 3.1.c.3 for list of medications).�

d. Patients must agree to have blood specimens submitted for pharmacokinetic analysis as outlined in Section 15.3.

Publication Information Expand/Collapse

2021

A Phase II Study of Talazoparib in Patients with Homologous Recombination Repair Deficiency (HRRD) Positive Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study S1400G)

T Owonikoko;M Redman;L Byers;F Hirsch;P Mack;L Schwartz;J Bradley;T Stinchcombe;N Lleighl;T Al Baghdadi;P Lara;J Miao;K Kelly;S Ramalingam;R Herbst;V Papadimitrakopoulou;D Gandara Clinical Lung Cancer May;22(3):187-194.e1. doi: 10.1016/j.cllc.2021.01.001. Epub 2021 Jan 10.

PMid: PMID33583720

Novel Clinical Trial Designs in Pursuit of Precision Oncology: Lung-MAP As a Model [Editorial]

J Riess;C Rolfo;D Gandara Clinical Lung Cancer May;22(3):153-155. doi: 10.1016/j.cllc.2021.03.013.

PMid: PMID33879399

2019

A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency (HRRD) Positive Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub- Study, S1400G)

T Owonikoko;M Redman;L Byers;F Hirsch;P Mack;L Schwartz;J Bradley;T Stinchcombe;N Leighl;T Al Baghdadi;P Lara;J Miao;K Kelly;S Ramalingam;R Herbst;V Papadimitrakopoulou;D Gandara J Clin Oncol 37(suppl; abstr 9022); ASCO (5/31/2019-6/4/2019, Chicago IL), poster discussion

2018

Prevalence and prognosis of DNA repair deficiency in squamous cell carcinoma (SCC) patients enrolled on the S1400 LungMAP study

T Owonikoko;M Redman;L Byers;K Griffin;F Hirsch;P Mack;D Gandara;JD Bradley;T Stinchcombe;K Kelly;S Ramalingam;R Herbst;V Papadimitrakopoulou J Clin Oncol 36, 2018 (suppl; abstr 9055); ASCO Annual Meeting (June 1- 5, 2018, Chicago, IL), poster 9055