Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer

August 4, 2026 updated by: Karen Reckamp, MD, MS

IIT2021-12-Reckamp-Osi105: Phase I Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer

The purpose of this study is to examine the combination of osimertinib and carotuximab to assess the safety and find the recommended dose for treatment of advanced EGFR-mutated non-small cell lung cancer (NSCLC). Safety and tolerability will be measured by the number of dose-limiting toxicities, according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 5, to find the maximum tolerated dose. The secondary objectives include evaluating the rate of objective response rate, duration of response, progression-free survival, and disease control rate, along with assessing biomarkers through tumor tissue and circulating tumor DNA.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Cedars-Sinai Cancer at Beverly Hills (THO)
        • Contact:
          • Clinical Trial Recruitment Navigator
      • Los Angeles, California, United States, 90048
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Cedars-Sinai Cancer at The Angeles Clinic and Research Institute
        • Contact:
          • Clinical Trial Recruitment Navigator
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Cancer at SOCC
        • Contact:
          • Clinical Trial Recruitment Navigator
      • Torrance, California, United States, 90505
        • Recruiting
        • Cedars-Sinai Cancer at Hunt Cancer Center - TMPNCC
        • Contact:
          • Clinical Trial Recruitment Navigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stage IV or recurrent/metastatic non-squamous NSCLC that harbors an EGFR activating mutation (Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q, etc). Local testing for EGFR mutations is acceptable provided it was performed in a CLIA certified lab.
  • Part I: Progressive disease on at least one prior EGFR TKI
  • Part II, Cohort 1: Progressive disease on osimertinib or other prior EGFR TKIs
  • Part II, Cohort 2: Receiving osimertinib as front line treatment for less than 12 weeks. Persistent ctDNA with EGFR mutation between weeks 6-12 from the start of osimertinib treatment.
  • Age at least 18
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
  • Archival tissue from a biopsy performed after progression of disease on previous EGFR TKI or willing to consent for a fresh tumor biopsy.
  • Measurable disease by RECIST 1.1.
  • Patients with untreated brain metastases are allowed provided that the patient is clinically asymptomatic and stable.
  • Patients must have completed prior chemotherapy ≥ 3 weeks or radiotherapy ≥ 2 weeks prior to receiving study drugs.
  • If the subject's most recent line of therapy is treatment with osimertinib, then all adverse events must be resolved to Grade 2 or better
  • If the subject's most recent line of therapy is any other treatment than osimertinib, then all Adverse Events must be resolved to grade 1 or better, with the exception of fatigue, alopecia and neuropathy (which must resolve to CTCAE grade 2).
  • Adequate organ function
  • Women of childbearing potential and men must agree to use adequate contraception while on study.
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

  • Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease.
  • Small cell lung cancer histology.
  • Other prior malignancy that might interfere with study endpoints per opinion of the investigator.
  • Prior exposure to carotuximab or any CD105 targeted antibody.
  • Any major surgical procedure within 2 weeks of starting therapy.
  • Patients must not have a history of uncontrolled or poorly-controlled hypertension defined as SBP > 150 mmHg or DBP > 90 mmHg within 28 days prior to enrollment.
  • Active bleeding or pathologic conditions that carries a high bleeding risk (e.g. gastric ulcers).
  • Use of thrombolytics within 10 days prior to the first day of carotuximab.
  • Known hypersensitivity to Chinese hamster ovary products or other recombinant human, chimeric, or humanized antibodies.
  • A known diagnosis of Osler-Weber-Rendu syndrome.
  • Ascites or pericardial or pleural effusion requiring external drainage procedures.
  • New evidence of leptomeningeal disease.
  • Acute cardiovascular event within the past 6 months.
  • Pregnancy or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Osimertinib with Carotuximab
Drug: Osimertinib
Osimertinib given by mouth daily at 40mg or 80mg depending on the starting dose level assigned per investigator. Therapy will continue until disease progression, patient withdrawal, or treatment intolerance.
Other Names:
  • TAGRISSO
Drug: Carotuximab
Carotuximab is administered intravenously weekly for the first 4 weeks, then every 2 weeks at 10mg/kg or 15 mg/kg depending on the starting dose level assigned per investigator. Therapy will continue until disease progression, patient withdrawal, or treatment intolerance.
Other Names:
  • TRC105
  • ENV105

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The number of adverse events and dose-limiting toxicities to find the Recommended Phase 2 Dose (RP2D) of combination of osimertinib with carotuximab in treatment of advanced, EGFR-mutated non-small cell lung cancer.
Time Frame: 4 weeks
The number of adverse events are graded by NCI CTCAE v5.0. The number of these dose-limiting toxicities (DLTs) experienced within the first treatment cycle (28 days) will be assessed to determine the RP2D.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: Assessed from baseline until the date of first documented progression, which is the end of treatment (EOT), assessed up to 2 years.
Proportion of participants with confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
Assessed from baseline until the date of first documented progression, which is the end of treatment (EOT), assessed up to 2 years.
Disease control rate
Time Frame: Assessed from baseline until EOT, up to 2 years.
Proportion of participants with confirmed CR, PR, or stable disease (SD) per RECIST v.1.1
Assessed from baseline until EOT, up to 2 years.
Duration of response
Time Frame: From baseline to first documentation of PD or death, whichever came first. Assessed up to 2 years.
Length of time from treatment response to progressive disease (PD) per RECIST v.1.1or death.
From baseline to first documentation of PD or death, whichever came first. Assessed up to 2 years.
Progression free survival.
Time Frame: Assessed from the time of treatment initiation (C1D1) until first documentation of progression, or death due to any cause, whichever came first. Assessed up to 2 years. One treatment cycle is 28 days.
From Cycle 1 Day 1 (C1D1) until first documentation of PD per RECIST v.1.1 or death due to any cause.
Assessed from the time of treatment initiation (C1D1) until first documentation of progression, or death due to any cause, whichever came first. Assessed up to 2 years. One treatment cycle is 28 days.
Biomarkers using tumor tissue and serial ctDNA for mutations.
Time Frame: From baseline until disease progression, or death, whichever came first. Assessed up to 2 years.
ctDNA will be evaluated for genomic alterations.
From baseline until disease progression, or death, whichever came first. Assessed up to 2 years.
Biomarkers of response to the combination using tumor tissue and serial ctDNA.
Time Frame: From baseline until disease progression, or death, whichever came first. Assessed up to 2 years.
ctDNA will be evaluated to correlate with response.
From baseline until disease progression, or death, whichever came first. Assessed up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karen Reckamp, MD, MS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Enviro Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen Reckamp, MD, MS, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT2021-12-Reckamp-Osi105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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