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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06816992




Registration number
NCT06816992
Ethics application status
Date submitted
3/02/2025
Date registered
10/02/2025

Titles & IDs
Public title
ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC
Scientific title
Phase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC
Secondary ID [1] 0 0
ORIC-114-05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
EGFR Exon 20 Insertion Mutations 0 0
NSCLC 0 0
EGFR-mutated NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ORIC-114 Dose 1 + amivantamab
Treatment: Drugs - ORIC-114 Dose 2 + amivantamab
Treatment: Drugs - ORIC-114 Dose 3 + amivanatamab

Experimental: Part 1 Dose Escalation level 1 - ORIC-114 + amivantamab

Experimental: Part 1 Dose Escalation level 2 - ORIC-114 + amivantamab

Experimental: Part 1 Dose Escalation level 3 - ORIC-114 + amivantamab

Experimental: Part 2 Dose Expansion - Two potential ORIC-114 dose levels + amivantamab


Treatment: Drugs: ORIC-114 Dose 1 + amivantamab
ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection

Treatment: Drugs: ORIC-114 Dose 2 + amivantamab
ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection

Treatment: Drugs: ORIC-114 Dose 3 + amivanatamab
ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recommended Phase 2 Dose (RP2D)
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Duration of response (DOR)
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
Progression-free survival (PFS)
Timepoint [4] 0 0
12 months
Secondary outcome [1] 0 0
Plasma PK parameters
Timepoint [1] 0 0
28 Days
Secondary outcome [2] 0 0
Plasma PK parameters
Timepoint [2] 0 0
28 Days
Secondary outcome [3] 0 0
Plasma PK parameters
Timepoint [3] 0 0
28 Days
Secondary outcome [4] 0 0
Plasma PK parameters
Timepoint [4] 0 0
28 Days
Secondary outcome [5] 0 0
BICR-Objective response rate (ORR)
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
BICR-Duration of response (DOR)
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
BICR-Progression-free survival (PFS)
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Intracranial Objective response rate (ORR)
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Intracranial Progression-free survival (PFS)
Timepoint [9] 0 0
12 months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed metastatic NSCLC with a documented EGFR exon 20 insertion mutation as determined locally by any nucleic acid-based diagnostic testing method; all tests should be performed in a CLIA certified or equivalently accredited laboratory
* Prior Therapies:

1. Dose Escalation: Patients may have previously received and progressed on or after platinum-based chemotherapy or may be treatment naïve
2. Dose Expansion: Patients must not have received any prior therapy; at time of enrollment, patients must decline, or be ineligible for all available standard of care therapies with proven benefit
* Agreement and ability to undergo a pretreatment biopsy, provided the procedure is clinically feasible and not deemed unsafe by the investigator
* Measurable disease according to RECIST 1.1
* Patients with asymptomatic CNS metastases are eligible
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known small cell lung cancer transformation
* Leptomeningeal disease
* Spinal cord compression not definitively treated with surgery or radiation
* Prior immunotherapy
* Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
* Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact absorption of ORIC-114

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
03000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Virginia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ORIC Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Janssen Research and Development LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pratik S. Multani, MD, MS
Address 0 0
ORIC Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ORIC Clinical
Address 0 0
Country 0 0
Phone 0 0
650-388-5600
Fax 0 0
Email 0 0
clinical@oricpharma.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06816992