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M1774 in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
M1774
Cemiplimab
Sponsored by
EMD Serono Research & Development Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor, M1774, Non squamous Non small cell lung cancer, Cemiplimab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants who are diagnosed with nsqNSCLC histologically or cytologically confirmed Participants with Radiologically confirmed/documented disease progression during or after the following systemic therapies (all required): At most, 1 line of anti-PD-(L)1 therapy for locally advanced or metastatic disease. Rechallenge with the same anti-PD-(L)1 for disease considered sensitive to anti-PD-(L)1 therapy (e.g. after a treatment break) is considered 1 line Platinum-based therapy for locally advanced or metastatic disease, given in combination or sequentially with anti-PD-(L)1 therapy. Participants who received adjuvant platinum-based therapy meet this criterion if disease progression occurred within 6 months from the last dose that the participant received that therapy. No additional cytotoxic therapies after progression on platinum-based therapy are allowed Prior best overall response of stable disease or better with anti-PD-(L)1 therapy Disease progression must have occurred while the participant has been receiving anti-PD-(L)1 therapy or within 16 weeks of the last dose of anti-PD-(L)1 therapy Participants with Measurable disease per RECIST v1.1 Participants with Eastern Cooperative Oncology Group (ECOG) PS 0 or 1 Adequate hematological, hepatic, and renal function as defined in the protocol. Phase 2a part only: central liquid biopsy analysis of tumor molecular alterations with an assay with appropriate regulatory status Other protocol defined inclusion criteria could apply Exclusion Criteria: Participants with tumors harboring actionable epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic aberrations. Participants with tumors with other actionable aberrations are eligible and allowed to have received up to 1 line of available targeted therapy Participants with history of additional malignancy within 3 years before the date of enrollment. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years Participants with known brain metastases, unless clinically stable Participant with history of (noninfectious) pneumonitis that required systemic corticosteroids or current pneumonitis/interstitial lung disease Other protocol defined exclusion criteria could apply

Sites / Locations

  • UPMC Cancer Center
  • Tennessee Cancer Specialists - Biomedical ResearchRecruiting
  • Millennium Research & Clinical DevelopmentRecruiting
  • Cancer Institute Hospital of JFCRRecruiting
  • Aichi Cancer Center HospitalRecruiting
  • Kindai University HospitalRecruiting
  • Kanagawa Cancer CenterRecruiting
  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dosing Regimen 1 (Phase 1b): M1774 + Cemiplimab

Dosing Regimen 2 (Phase 1b): M1774 + Cemiplimab

Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b

Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b

Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b

Arm Description

Outcomes

Primary Outcome Measures

Phase 1b/Phase 2a: Confirmed Overall response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 As assessed by Investigator
Phase 1b: Number of Participants With Adverse Events (AEs) and Treatment-related AEs

Secondary Outcome Measures

Phase 1b/Phase 2a: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator
Phase 1b/Phase 2a: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator
Phase 1b/Phase 2a: Overall survival (OS)
Phase 2a: Number of Participants With AEs and Treatment-related AEs

Full Information

First Posted
May 22, 2023
Last Updated
October 11, 2023
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05882734
Brief Title
M1774 in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)
Official Title
An Open Label, Multicenter, Phase 1b/2a Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of the ATR Inhibitor M1774 in Combination With Cemiplimab in Participants With Non-Squamous Non-Small Cell Lung Cancer That Has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies (DDRiver NSCLC 322)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2023 (Actual)
Primary Completion Date
August 25, 2026 (Anticipated)
Study Completion Date
September 3, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an Open-label, multicenter clinical study conducted in two Phases to establish the efficacy, safety, tolerability, and pharmacokinetics of the ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor M1774 in Combination with Cemiplimab in Participants with Non-Squamous Non-Small Cell Lung Cancer (nsqNSCLC) that has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor, M1774, Non squamous Non small cell lung cancer, Cemiplimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dosing Regimen 1 (Phase 1b): M1774 + Cemiplimab
Arm Type
Experimental
Arm Title
Dosing Regimen 2 (Phase 1b): M1774 + Cemiplimab
Arm Type
Experimental
Arm Title
Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
Arm Type
Experimental
Arm Title
Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
Arm Type
Experimental
Arm Title
Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
M1774
Intervention Description
In Phase 1b, M1774 will be administered as dosing regimen 1 or dosing regimen 2 until disease progression, death discontinuation criteria or any other reason. The selected dosing regimen of M1774 will be administered in all arms of Phase 2a.
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Intervention Description
Cemiplimab will be administered as an intravenous infusion every 3 weeks in all arms of Phase 1b and Phase 2a until disease progression, death discontinuation criteria or any other reason.
Primary Outcome Measure Information:
Title
Phase 1b/Phase 2a: Confirmed Overall response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 As assessed by Investigator
Time Frame
Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months
Title
Phase 1b: Number of Participants With Adverse Events (AEs) and Treatment-related AEs
Time Frame
Time from randomization to final assessment at end of safety follow-up visit approximately up to 3 years and 2 months
Secondary Outcome Measure Information:
Title
Phase 1b/Phase 2a: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator
Time Frame
Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months
Title
Phase 1b/Phase 2a: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator
Time Frame
Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months
Title
Phase 1b/Phase 2a: Overall survival (OS)
Time Frame
Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months
Title
Phase 2a: Number of Participants With AEs and Treatment-related AEs
Time Frame
Time from randomization to final assessment at end of safety follow-up visit (approximately up to 3 years and 2 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who are diagnosed with nsqNSCLC histologically or cytologically confirmed Participants with Radiologically confirmed/documented disease progression during or after the following systemic therapies (all required): At most, 1 line of anti-PD-(L)1 therapy for locally advanced or metastatic disease. Rechallenge with the same anti-PD-(L)1 for disease considered sensitive to anti-PD-(L)1 therapy (e.g. after a treatment break) is considered 1 line Platinum-based therapy for locally advanced or metastatic disease, given in combination or sequentially with anti-PD-(L)1 therapy. Participants who received adjuvant platinum-based therapy meet this criterion if disease progression occurred within 6 months from the last dose that the participant received that therapy. No additional cytotoxic therapies after progression on platinum-based therapy are allowed Prior best overall response of stable disease or better with anti-PD-(L)1 therapy Disease progression must have occurred while the participant has been receiving anti-PD-(L)1 therapy or within 16 weeks of the last dose of anti-PD-(L)1 therapy Participants with Measurable disease per RECIST v1.1 Participants with Eastern Cooperative Oncology Group (ECOG) PS 0 or 1 Adequate hematological, hepatic, and renal function as defined in the protocol. Phase 2a part only: central liquid biopsy analysis of tumor molecular alterations with an assay with appropriate regulatory status Other protocol defined inclusion criteria could apply Exclusion Criteria: Participants with tumors harboring actionable epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic aberrations. Participants with tumors with other actionable aberrations are eligible and allowed to have received up to 1 line of available targeted therapy Participants with history of additional malignancy within 3 years before the date of enrollment. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years Participants with known brain metastases, unless clinically stable Participant with history of (noninfectious) pneumonitis that required systemic corticosteroids or current pneumonitis/interstitial lung disease Other protocol defined exclusion criteria could apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Medical Information
Phone
888-275-7376
Email
eMediUSA@emdserono.com
First Name & Middle Initial & Last Name or Official Title & Degree
Communication Center
Phone
+49 6151 72 5200
Email
service@emdgroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
UPMC Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Tennessee Cancer Specialists - Biomedical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
pi@biomed-research.com
First Name & Middle Initial & Last Name & Degree
Tracy W Dobbs
Facility Name
Millennium Research & Clinical Development
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
wjeong@wmrad.com
First Name & Middle Initial & Last Name & Degree
Woondong Jeong
Facility Name
Cancer Institute Hospital of JFCR
City
Koto-ku
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
ryo.ariyasu@jfcr.or.jp
First Name & Middle Initial & Last Name & Degree
Ryo Ariyasu
Facility Name
Aichi Cancer Center Hospital
City
Nagoya-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
y.fujiwara@aichi-cc.jp
First Name & Middle Initial & Last Name & Degree
Yutaka Fujiwara
Facility Name
Kindai University Hospital
City
Osakasayama-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
s.suzuki-oncologist@med.kindai.ac.jp
First Name & Middle Initial & Last Name & Degree
Shinichiro Suzuki
Facility Name
Kanagawa Cancer Center
City
Yokohama-shi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Email
saito-h@kcch.jp
First Name & Middle Initial & Last Name & Degree
Haruhiro Saito
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
sehoon.lee119@gmail.com
First Name & Middle Initial & Last Name & Degree
Se-Hoon Lee

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS201924_0022
Description
Trial Awareness and Transparency website
URL
https://medical.emdserono.com/en_US/home.html
Description
US Medical Information website, Medical Resources

Learn more about this trial

M1774 in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

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