Health TrialsbyHealthPanel

A Study of Valemetostat in Combination With Atezolizumab in People With Lung Cancer

ConditionExtensive-stage Small-cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

This study will test whether valemetostat in combination with atezolizumab is a safe treatment that causes few or mild side effects in people with extensive-stage small cell lung cancer (SCLC). The researchers will test different doses of valemetostat to find the highest dose that causes few or mild side effects in participants. After the dose is found, researchers will test it in a new group of participants to learn more about the safety of the study treatment and see if it is an effective treatment for extensive-stage SCLC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent form (ICF)

Ability to comply with the study protocol as per the investigator's judgment

Age ≥ 18 years at the time of signing the ICF

Life expectancy ≥ 12 weeks

Disqualifiers

Any active uncontrolled systemic diseases or other medical conditions considered to be poorly controlled by the investigator including but not limited to bleeding diatheses, that could in the investigator's opinion, potentially interfere with completion of study procedures or interpretation of study outcomes.

Patients who receive consolidative chest radiation after completion of initial chemotherapy and immunotherapy.

Symptomatic CNS metastases

Patients with treated CNS metastases are allowed on the study if their clinical symptoms are adequately controlled and the daily dose of steroid use is equivalent to or less than 10 mg of prednisone.

Trial design

Design model

Single group

Treatments tested in this trial

  • Valemetostat

    Drug

    Dose level -1 100 mg po once daily Dose level 1 150 mg po once daily Dose level 2 200 mg po once daily

  • Atezolizumab

    Drug

    1680 mg IV q4weeks

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Valemetostat in Combination With AtezolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Determine Phase II dose (RP2D)

The Common Terminology Criteria for Adverse Events (CTCAE) 5.0 will be used to determine all adverse events and dose-limiting toxicities.

Time frame
1 year

Secondary outcomes

1

Progression-free survival (PFS)

The Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria will be used to determine progression-free survival

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Daiichi Sankyo

Collaborator

Source ClinicalTrials.gov
Apply now