Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Ludwig Institute for Cancer Research
Study ID
NCT02898116
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ensartinib — DRUG
    Ensartinib was administered orally once daily at a dose of 200 mg during the Run-in Period. During combination therapy, the ensartinib starting dose was to be 200 mg. Based on observed toxicity at the starting dose level, the ensartinib dose may have been escalated to the recommended single-agent dose (225 mg) or de-escalated to the minimum effective dose (150 mg).
  • Durvalumab — DRUG
    During combination therapy, durvalumab was to be administered as an IV infusion over 60 (± 5) minutes every 4 weeks at a dose of 1500 mg.

Study Details

This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed cell death ligand 1 (PD-L1) antibody, in subjects with ALK-rearranged (ALK-positive) non-small cell lung cancer (NSCLC). Primary study objectives were to determine the recommended combination dose (RCD) and safety and tolerability of the combination. Further objectives were to evaluate the clinical efficacy and biologic activity of the combination.

Key Dates

Start date
May 10, 2017
Status verified
Oct 2022
Primary completion
Aug 4, 2017
Completion
Aug 4, 2017

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ensartinib ± Durvalumab
    Subjects were to receive ensartinib monotherapy during a pre-immunotherapy Run-in Period for one to two 28-day cycles, followed by combination therapy with ensartinib plus durvalumab for subjects with no DLTs during the Run-in Period.

Primary Outcome Measure

Number of Subjects With Treatment-emergent Adverse Events [ Time Frame: up to 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research FacilityNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Research Facility· New York, NY

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