Non Small Cell Lung CancerPhase 1NCT05401110
Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
A Phase 1 study testing Osimertinib and Carotuximab in people with Non Small Cell Lung Cancer and Lung Cancer, run by Karen Reckamp, MD, MS at 5 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Lung Cancer
- What is being tested?
- Osimertinib and Carotuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Sep 2023to Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Cedars-Sinai Cancer at Beverly Hills (THO)
Beverly Hills, California, 90211
Clinical Trial Recruitment Navigator
- Recruiting
Cedars-Sinai Cancer at The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Clinical Trial Recruitment Navigator
- Recruiting
Cedars-Sinai Cancer at SOCC
Los Angeles, California, 90048
Clinical Trial Recruitment Navigator
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Clinical Trial Recruitment Navigator, 310-423-5842, GroupCancerTrialInformation@cshs.org
- Recruiting
Cedars-Sinai Cancer at Hunt Cancer Center - TMPNCC
Torrance, California, 90505
Clinical Trial Recruitment Navigator
About this study
Official title: 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.
- Conditions
- Non Small Cell Lung Cancer, Lung Cancer
- Being tested
- Osimertinib, Carotuximab
- Keywords
- EGFR, Osimertinib, Carotuximab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
Also called TAGRISSO
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.
CarotuximabDrug
Also called ENV105, TRC105
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.
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib with Carotuximab | Experimental | Not described Receives: Drug: Osimertinib; Drug: Carotuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 4 weeks
Secondary outcomes (6)
Objective response rate
Proportion of participants with confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
Measured: 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
Proportion of participants with confirmed CR, PR, or stable disease (SD) per RECIST v.1.1
Measured: Assessed from baseline until EOT, up to 2 years.
Duration of response
Length of time from treatment response to progressive disease (PD) per RECIST v.1.1or death.
Measured: From baseline to first documentation of PD or death, whichever came first. Assessed up to 2 years.
Progression free survival.
From Cycle 1 Day 1 (C1D1) until first documentation of PD per RECIST v.1.1 or death due to any cause.
Measured: 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.
ctDNA will be evaluated for genomic alterations.
Measured: 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.
ctDNA will be evaluated to correlate with response.
Measured: From baseline until disease progression, or death, whichever came first. Assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start15 Sep 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm phase I dose escalation study with expansion cohorts. 1. Part I: Progressive disease on at least one prior EGFR TKI 2. Part II, Cohort 1: Progressive disease on osimertinib or other prior EGFR TKIs 3. 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karen Reckamp, MD, MS
- Sponsor type
- University, hospital or other
- Collaborators
- Enviro Therapeutics, Inc.
- Responsible party
- Sponsor-investigator, Karen Reckamp, MD, MS, Cedars-Sinai Medical Center
- Investigators
- Karen Reckamp, MD, MS, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401110
- Sponsor's protocol ID
- IIT2021-12-Reckamp-Osi105
- Status last verified
- Aug 2026
- First submitted
- 23 May 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2021-12-Reckamp-Osi105: Phase I Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05401110
- Acronym / sponsor ID
- IIT2021-12-Reckamp-Osi105
- Conditions
- Non Small Cell Lung Cancer, Lung Cancer
- Keywords
- EGFR, Osimertinib, Carotuximab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karen Reckamp, MD, MSUniversity, hospital or other
- Collaborators
- Enviro Therapeutics, Inc.
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm phase I dose escalation study with expansion cohorts. 1. Part I: Progressive disease on at least one prior EGFR TKI 2. Part II, Cohort 1: Progressive disease on osimertinib or other prior EGFR TKIs 3. 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.
| Arm | Type | Receives |
|---|---|---|
| Osimertinib with Carotuximab | Experimental | Drug: Osimertinib, Drug: Carotuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| OsimertinibAlso: TAGRISSOOsimertinib 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. | Drug | Osimertinib with Carotuximab |
| CarotuximabAlso: ENV105, TRC105Carotuximab 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. | Drug | Osimertinib with Carotuximab |
Primary outcome
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.
6 secondary outcomes
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.
Disease control rate
Time frame: 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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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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.
Karen Reckamp, MD, MS principal investigator
Cedars-Sinai Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Osimertinib and Carotuximab in people with Non Small Cell Lung Cancer and Lung Cancer, run by Karen Reckamp, MD, MS at 5 sites in United States.
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 15 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Recruitment Navigator (310-423-5842, GroupCancerTrialInformation@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.