NSCLC, Stage IVPhase 2RAINNCT03805841
Study of Tarloxotinib in Pts With NSCLC (EGFR Exon 20 Insertion, HER2-activating Mutations) & Other Solid Tumors With NRG1/ERBB Gene Fusions
A Phase 2 study testing tarloxotinib bromide in people with NSCLC, Stage IV and NSCLC Stage IIIB, run by Rain Oncology Inc at 14 sites in 3 countries.
Trial summary
Open-label, Phase 2, single treatment arm, 3 cohorts Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Stage IV, NSCLC Stage IIIB, NSCLC, Stage IIIC
- What is being tested?
- tarloxotinib bromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 13 Mar 2019to 23 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically confirmed primary diagnosis of NSCLC, Stage IV, Stage IIIB or IIIC not amenable to definitive curative intent therapy, or recurrent disease after prior diagnosis of Stage I-III disease. Cohort C locally advanced or metastatic solid tumor.
- Progression of disease on or after a platinum-based chemotherapy regimen (Cohorts A and B) or after standard of care (Cohort C)
- EGFR exon 20 insertion mutation (Cohort A) or HER2 activating mutation (Cohort B) or NRG1 or ERBB family gene fusions (Cohort C)
- Measurable disease according to RECIST v.1.1
- ECOG performance status of 0 or 1
- Serum creatinine ≤ 1.5 x ULN (or calculated creatinine clearance ≥ 60 mL/min using Cockcroft Gault equation)
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- Total bilirubin: ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of liver metastases
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN, in the presence of liver metastases
- Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
- Hemoglobin ≥ 9 g/dL or 5.6 mmol/L
- Platelet count ≥ 100,000/μL
- No evidence of second or third degree atrioventricular block
- No clinically significant arrhythmia (i.e.; pauses of > 4 seconds, VT of any duration, SVT > 4 beats/minute)
- QRS interval ≤ 110 ms
- QTcF interval of < 450 ms
- PR interval ≤ 200 ms
- Adequate pretreatment tumor sample (125 µm of FFPE block or at least 8 prepared slides)
Who cannot join
- Another known activating oncogene driver mutation
- (Cohorts A and B Only) Previously received anti EGFR or anti HER2 tyrosine kinase inhibitors
- (Cohorts A and B Only) Previously received anti EGFR or anti HER2 monoclonal antibodies or EGFR or HER2 antibody drug conjugates
- Investigational therapy administered within the 28 days or 5 half lives
- Chemotherapy or radiation within 14 days prior to Cycle 1 Day 1
- Immunotherapy within 21 days
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- Clinically active or symptomatic interstitial lung disease (ILD) or interstitial pneumonitis, or a history of clinically significant ILD or radiation pneumonitis
- Untreated and/or symptomatic CNS malignancies (primary or metastatic);
- Receiving medication that prolongs QT interval, with a risk of causing Torsade de Pointes (TdP)
- Personal or familial history of Long QT Syndrome
- NYHA class III or IV or LVEF < 55%
- Myocardial infarction, severe or unstable angina within 6 months
- History of TdP, ventricular arrhythmia
- Significant thrombotic or embolic events within 3 months
- Uncontrolled or severe cardiovascular disease
- Concurrent malignancy expected to require treatment within 2 years or interfere with study outcomes
- History of severe allergic reactions or hypersensitivity to compounds of similar chemical or biologic composition as tarloxotinib
- Known HIV infection or active Hepatitis B or C
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States11 sites
RAIN-701 Study Site
Aurora, Colorado, 80045
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Henry Ford Cancer Institute
Detroit, Michigan, 48202
RAIN-701 Study Site
Irvine, California, 92697
Pacific Shores Medical Group
Long Beach, California, 90813
Comprehensive Care and Research Center, Atlanta
Newnan, Georgia, 30265
RAIN-701 Study Site
Pittsburgh, Pennsylvania, 15232
Providence Cancer Institute
Portland, Oregon, 97213
University of California San Francisco, Helen Diller Cancer Center
San Francisco, California, 94158
RAIN-701 Study Site
Seattle, Washington, 98109
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Hong Kong2 sites
RAIN-701 Study Site
Hong Kong
Hong Kong United Oncology Center
Kowloon
About this study
Official title: Phase 2 Study - Evaluate the Clinical Activity of Tarloxotinib in Patients With Non-Small Cell Lung Cancer That Harbors an EGFR Exon 20 Insertion or HER2-Activating Mutation and Other Advanced Solid Tumors With NRG1/ERBB Family Gene Fusions
Open-label, Phase 2, single treatment arm, 3 cohorts
- Conditions
- NSCLC, Stage IV, NSCLC Stage IIIB, NSCLC, Stage IIIC, NSCLC, Recurrent, EGFR Exon 20 Insertion Mutation, HER2-activating Mutation
- Being tested
- tarloxotinib bromide
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tarloxotinib bromideDrug
Also called Tarlox, tarloxotinib
weekly intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | tarloxotinib bromide Receives: Drug: tarloxotinib bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The primary objective of this study is to evaluate the objective response rate (ORR) of tarloxotinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for tumors assessed by CT or MRI: Complete Response (CR) - Disappearance of all target lesions and reduction in the short axis measurement of all pathologic lymph nodes to ≤10 mm. Partial Response (PR) - ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline.
The overall response rate in each cohort will be estimated as the number of subjects with a confirmed objective response (CR or PR) divided by the number of enrolled subjects in each respective cohort.
Measured: Through study completion, an average of 10 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start13 Mar 2019
- Primary completion9 Apr 2021
- Study completion23 Apr 2021
Why it stopped: enrollment pause
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLC, Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rain Oncology Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen V Liu, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805841
- Sponsor's protocol ID
- RAIN-701
- Acronym
- RAIN
- Status last verified
- Apr 2023
- First submitted
- 11 Jan 2019
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No Plan
Publications
Ye L, Chen X, Zhou F. EGFR-mutant NSCLC: emerging novel drugs. Curr Opin Oncol. 2021 Jan;33(1):87-94. doi: 10.1097/CCO.0000000000000701.
PubMed 33122578
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study - Evaluate the Clinical Activity of Tarloxotinib in Patients With Non-Small Cell Lung Cancer That Harbors an EGFR Exon 20 Insertion or HER2-Activating Mutation and Other Advanced Solid Tumors With NRG1/ERBB Family Gene Fusions
- ClinicalTrials.gov ID
- NCT03805841
- Acronym / sponsor ID
- RAIN / RAIN-701
- Conditions
- NSCLC, Stage IV, NSCLC Stage IIIB, NSCLC, Stage IIIC, NSCLC, Recurrent, EGFR Exon 20 Insertion Mutation, HER2-activating Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment pause
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Rain Oncology IncIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Posted 28 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, Phase 2, single treatment arm, 3 cohorts
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: tarloxotinib bromidetarloxotinib bromide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically and/or cytologically confirmed primary diagnosis of NSCLC, Stage IV, Stage IIIB or IIIC not amenable to definitive curative intent therapy, or recurrent disease after prior diagnosis of Stage I-III disease. Cohort C locally advanced or metastatic solid tumor.
- Progression of disease on or after a platinum-based chemotherapy regimen (Cohorts A and B) or after standard of care (Cohort C)
- EGFR exon 20 insertion mutation (Cohort A) or HER2 activating mutation (Cohort B) or NRG1 or ERBB family gene fusions (Cohort C)
- Measurable disease according to RECIST v.1.1
- ECOG performance status of 0 or 1
Key exclusion criteria (18 listed)
- Another known activating oncogene driver mutation
- (Cohorts A and B Only) Previously received anti EGFR or anti HER2 tyrosine kinase inhibitors
- (Cohorts A and B Only) Previously received anti EGFR or anti HER2 monoclonal antibodies or EGFR or HER2 antibody drug conjugates
- Investigational therapy administered within the 28 days or 5 half lives
- Chemotherapy or radiation within 14 days prior to Cycle 1 Day 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tarloxotinib bromideAlso: Tarlox, tarloxotinibweekly intravenous infusion | Drug | Active |
Primary outcome
ORR
Time frame: Through study completion, an average of 10 months.
The primary objective of this study is to evaluate the objective response rate (ORR) of tarloxotinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for tumors assessed by CT or MRI: Complete Response (CR) - Disappearance of all target lesions and reduction in the short axis measurement of all pathologic lymph nodes to ≤10 mm. Partial Response (PR) - ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline. The overall response rate in each cohort will be estimated as the number of subjects with a confirmed objective response (CR or PR) divided by the number of enrolled subjects in each respective cohort.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33122578Ye L, Chen X, Zhou F. EGFR-mutant NSCLC: emerging novel drugs. Curr Opin Oncol. 2021 Jan;33(1):87-94. doi: 10.1097/CCO.0000000000000701.
- Individual participant dataSharing planned: No. No Plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen V Liu, MD principal investigator
Georgetown University
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tarloxotinib bromide in people with NSCLC, Stage IV and NSCLC Stage IIIB, run by Rain Oncology Inc at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Hong Kong, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Through study completion, an average of 10 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03805841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.