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History of Changes for Study: NCT04620330
A Study of VS-6766 v. VS-6766 + Defactinib in Recurrent G12V or Other KRAS-Mutant Non-Small Cell Lung Cancer
Latest version (submitted January 11, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 5, 2020 None (earliest Version on record)
2 November 6, 2020 Outcome Measures, Study Description and Study Status
3 January 4, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 January 13, 2021 Contacts/Locations and Study Status
5 January 19, 2021 Contacts/Locations and Study Status
6 January 28, 2021 Contacts/Locations and Study Status
7 January 29, 2021 Contacts/Locations and Study Status
8 February 3, 2021 Study Status and Contacts/Locations
9 February 8, 2021 Contacts/Locations and Study Status
10 February 11, 2021 Contacts/Locations and Study Status
11 February 17, 2021 Contacts/Locations and Study Status
12 February 17, 2021 Contacts/Locations and Study Status
13 February 19, 2021 Contacts/Locations and Study Status
14 March 5, 2021 Study Status and Contacts/Locations
15 March 9, 2021 Contacts/Locations and Study Status
16 March 10, 2021 Contacts/Locations and Study Status
17 March 15, 2021 Contacts/Locations and Study Status
18 March 17, 2021 Contacts/Locations and Study Status
19 March 18, 2021 Contacts/Locations and Study Status
20 March 29, 2021 Contacts/Locations and Study Status
21 April 8, 2021 Contacts/Locations and Study Status
22 May 13, 2021 Contacts/Locations and Study Status
23 May 17, 2021 Contacts/Locations and Study Status
24 May 18, 2021 Contacts/Locations and Study Status
25 May 25, 2021 Contacts/Locations and Study Status
26 June 1, 2021 Contacts/Locations and Study Status
27 June 14, 2021 Contacts/Locations and Study Status
28 June 29, 2021 Study Status and Contacts/Locations
29 July 2, 2021 Contacts/Locations and Study Status
30 July 7, 2021 Study Status and Contacts/Locations
31 July 13, 2021 Contacts/Locations and Study Status
32 July 23, 2021 Contacts/Locations and Study Status
33 August 6, 2021 Study Status, Contacts/Locations and Study Identification
34 August 12, 2021 Contacts/Locations and Study Status
35 August 17, 2021 Contacts/Locations and Study Status
36 August 19, 2021 Contacts/Locations and Study Status
37 August 20, 2021 Contacts/Locations and Study Status
38 August 25, 2021 Contacts/Locations and Study Status
39 September 17, 2021 Contacts/Locations and Study Status
40 October 1, 2021 Study Status and Contacts/Locations
41 October 18, 2021 Contacts/Locations and Study Status
42 October 27, 2021 Contacts/Locations and Study Status
43 October 28, 2021 Contacts/Locations and Study Status
44 November 2, 2021 Contacts/Locations and Study Status
45 December 7, 2021 Contacts/Locations and Study Status
46 December 8, 2021 Contacts/Locations and Study Status
47 December 15, 2021 Contacts/Locations and Study Status
48 December 21, 2021 Contacts/Locations and Study Status
49 December 22, 2021 Contacts/Locations and Study Status
50 January 5, 2022 Contacts/Locations and Study Status
51 January 19, 2022 Contacts/Locations and Study Status
52 January 27, 2022 Contacts/Locations and Study Status
53 February 11, 2022 Study Identification, Contacts/Locations, Study Status, Eligibility and Conditions
54 March 7, 2022 Contacts/Locations and Study Status
55 March 10, 2022 Contacts/Locations and Study Status
56 June 22, 2022 Arms and Interventions, Outcome Measures, Contacts/Locations, Study Status, Conditions, Study Description and Study Identification
57 July 14, 2022 Study Status and Contacts/Locations
58 July 19, 2022 Contacts/Locations and Study Status
59 December 22, 2022 Contacts/Locations, Arms and Interventions, Study Description, Study Status, Study Identification and Outcome Measures
60 January 11, 2024 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Study NCT04620330
Submitted Date:  November 5, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: VS-6766-202
Brief Title: A Study of VS-6766 v. VS-6766 + Defactinib in Recurrent G12V or Other KRAS-Mutant Non-Small Cell Lung Cancer
Official Title: A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination With Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) Non-Small Cell Lung Cancer (NSCLC)
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Not yet recruiting
Study Start: November 2020
Primary Completion: March 2023 [Anticipated]
Study Completion: December 2025 [Anticipated]
First Submitted: November 5, 2020
First Submitted that
Met QC Criteria:
November 5, 2020
First Posted: November 6, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 5, 2020
Last Update Posted: November 6, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Verastem, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study will assess the safety and preliminary efficacy of VS-6766 monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.
Detailed Description: This is a multicenter, non-randomized, open-label Phase 1b/2 study designed to evaluate safety and tolerability and efficacy of VS-6766 versus VS-6766 in combination with defactinib in subjects with KRAS-MT NSCLC following treatment with an appropriate platinum-based regimen and an approved immune checkpoint inhibitor (CPI).
Open or close this module Conditions
Conditions: Non Small Cell Lung Cancer
KRAS Activating Mutation
Keywords: NSCLC
KRAS-G12V
G12V
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Part A
To determine the optimal regimen, either VS-6766 monotherapy or VS-6766 in combination with defactinib, for subsequent evaluation for efficacy in the expansion phase (Part B).
Drug: VS-6766
Monotherapy
Drug: VS-6766 and Defactinib
Combination therapy
Other Names:
  • VS-6766 and VS-6063
Experimental: Part B
To determine the efficacy of the optimal regimen identified from Part A
Drug: VS-6766
Monotherapy
Drug: VS-6766 and Defactinib
Combination therapy
Other Names:
  • VS-6766 and VS-6063
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Part A: To determine the optimal regimen, either VS-6766 monotherapy or VS-6766 in combination with defactinib,
[ Time Frame: From start of treatment to confirmation of response; 24 weeks ]

Confirmed overall response rate per RECIST 1.1
2. Part B: To determine the efficacy of the optimal regimen identified from Part A
[ Time Frame: From start of treatment to confirmation of response; 24 weeks ]

Confirmed overall response rate per RECIST 1.1
Secondary Outcome Measures:
1. Overall Response Rate as assessed by Investigator
[ Time Frame: From start of treatment to confirmation of response; 24 weeks ]

Proportioned subjects achieving a CR or PR as assess by the investigator
2. Duration of Response (DOR)
[ Time Frame: Time from the first documentation of response to first documentation of progressive disease or death due to any cause, greater than or equal to 8 months ]

Time of first response to PD as assessed by the IRC
3. Disease Control Rate (DCR)
[ Time Frame: Greater than or equal to 8 weeks ]

CR and PR stable disease as assessed by the IRC
4. Progression Free Survival (PFS)
[ Time Frame: Up to 5 years ]

From the time of first dose of study intervention to PD or death from any cause
5. Overall Survival (OS)
[ Time Frame: Up to 5 years ]

From time of first dose of study intervention to death
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Male or female subjects ≥ 18 years of age
  • Histologic or cytologic evidence of NSCLC
  • Known KRAS mutation
  • The subject must have received appropriate prior therapy
  • Measurable disease according to RECIST 1.1
  • An Eastern Cooperative Group (ECOG) performance status ≤ 1
  • Adequate organ function
  • Adequate recovery from toxicities related to prior treatments
  • Agreement to use highly effective method of contraceptive

Exclusion Criteria:

  • Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
  • History of prior malignancy, with the exception of curatively treated malignancies
  • Major surgery within 4 weeks (excluding placement of vascular access)
  • History of treatment with a direct and specific inhibitor of MEK or KRAS
  • Exposure to strong CYP2C9 and CYP3A4 inhibitors or inducers within 7 days prior to the first dose and during the course of therapy
  • Symptomatic brain metastases requiring steroids or other local interventions.
  • Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy
  • Active skin disorder that has required systemic therapy within the past 1 year
  • History of rhabdomyolysis
  • Concurrent ocular disorders
  • Concurrent heart disease or severe obstructive pulmonary disease
  • Subjects with the inability to swallow oral medications
Open or close this module Contacts/Locations
Central Contact Person: Gloria Patrick
Telephone: 781-469-1594
Email: gpatrick@verastem.com
Central Contact Backup: Kate Adams-Loeffler
Telephone: 781-469-1038
Email: kadams@verastem.com
Study Officials: Ross Camidge, MD, PhD
Principal Investigator
University of Colorado, Denver
Hagop Youssoufian, MD
Study Director
Verastem, Inc.
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services