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Tuvusertib (M1774) in Combination with Cemiplimab in Participants with Non-Squamous NSCLC (DDRiver NSCLC 322)
EU CTIS ID: 2022-502010-85-00
What this study is testing
1. Phase 1b: To assess efficacy in terms of objective response (OR), safety, and tolerability of interventions of Tuvusertib in combination with cemiplimab, to support selection of a dosing regimen for the Phase 2a part 2. Phase 1b: To evaluate the safety and tolerability of Tuvusertib in combination with cemiplimab to support selection of dosing regimen for Phase 2a 3. Phase 2a: To assess efficacy of intervention in terms of OR with Tuvusertib in combination with cemiplimab
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Are ≥ 18 years of age at the time of signing the informed consent
- Are diagnosed with nsqNSCLC histologically or cytologically confirmed
- Radiologically confirmed/documented disease progression during or after the following systemic therapies (all required): •a. At most, 1 line of anti-PD-(L)1 therapy for locally advanced or metastatic disease. Note 1: 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. Note 2: this includes (neo)adjuvant anti-PD-(L)1 therapy for locally advanced disease, provided disease progression occurs within 16 weeks of the last dose of anti-PD-(L)1 therapy. •b. Platinum-based therapy for locally advanced or metastatic disease, given in combination or sequentially with anti-PD-(L)1 therapy. Participants who received (neo)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 •c. Prior best overall response of stable disease or better with anti-PD-(L)1 therapy •d. 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
- Measurable disease per RECIST v1.1, as assessed by the Investigator
- ECOG PS 0 or 1
- Adequate hematological, hepatic and renal function as defined in the protocol.
You likely can't join if
- Participants with tumors harboring actionable EGFR or 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
- 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
- Known brain metastases, unless clinically stable
- history of (noninfectious) pneumonitis that required systemic corticosteroids or current pneumonitis/interstitial lung disease
- Other protocol defined inclusion criteria could apply.
See the full eligibility criteria
- Are ≥ 18 years of age at the time of signing the informed consent
- Are diagnosed with nsqNSCLC histologically or cytologically confirmed
- Radiologically confirmed/documented disease progression during or after the following systemic therapies (all required): •a. At most, 1 line of anti-PD-(L)1 therapy for locally advanced or metastatic disease. Note 1: 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. Note 2: this includes (neo)adjuvant anti-PD-(L)1 therapy for locally advanced disease, provided disease progression occurs within 16 weeks of the last dose of anti-PD-(L)1 therapy. •b. Platinum-based therapy for locally advanced or metastatic disease, given in combination or sequentially with anti-PD-(L)1 therapy. Participants who received (neo)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 •c. Prior best overall response of stable disease or better with anti-PD-(L)1 therapy •d. 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
- Measurable disease per RECIST v1.1, as assessed by the Investigator
- ECOG PS 0 or 1
- Adequate hematological, hepatic and renal function as defined in the protocol.
- Archival FFPE tumor tissue is available or tumor genomic profiling with a NGS based test performed in a certified laboratory and PD-L1 status as determined by an assay of appropriate regulatory status are required.
- Phase 2a part only: central liquid biopsy analysis of tumor molecular alterations with an assay with appropriate regulatory status. Participants will be allocated to Stratum A, B and C as defined in the protocol.
- Other protocol defined inclusion criteria could apply
- Participants with tumors harboring actionable EGFR or 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
- 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
- Known brain metastases, unless clinically stable
- history of (noninfectious) pneumonitis that required systemic corticosteroids or current pneumonitis/interstitial lung disease
- Other protocol defined inclusion criteria could apply.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- China
- Serbia
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; China; Serbia; United States; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.