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Osimertinib

Phase 1

Non Small Cell Lung Cancer | Small molecule | Oncology |Kairos Pharma, Ltd.|Last Updated: Aug 6, 2026

Target and mechanism

Molecular targetEGFR
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Osimertinib · 1 trial · 2 indications

Phase 1 1
NCT05401110Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung CancerNon Small Cell Lung Cancer
RECRUITING60 Analytics
PHASE1RECRUITING
Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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.
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.

Secondary Endpoints

Objective response rate
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
Assessed from baseline until EOT, up to 2 years.
Duration of response
From baseline to first documentation of PD or death, whichever came first. Assessed up to 2 years.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Osimertinib with CarotuximabEXPERIMENTAL -

Interventions

NameTypeDescription
OsimertinibDRUGOsimertinib 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.
CarotuximabDRUGCarotuximab 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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: Progre...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Non Small Cell Lung Cancer")

Frequently asked questions about Osimertinib

What is Osimertinib used for in Non Small Cell Lung Cancer?

Osimertinib is being studied for the treatment of Non Small Cell Lung Cancer (NSCLC), specifically in patients with EGFR-mutated advanced disease. It is an investigational small molecule being evaluated in a Phase 1 clinical trial in combination with carotuximab. The drug is not yet approved and remains in clinical development.

What does Osimertinib target?

Osimertinib is a kinase inhibitor, as indicated by its '-tinib' suffix, which means it targets kinases involved in cancer cell growth. In the context of the ongoing trial, it is being studied in EGFR-mutated Non Small Cell Lung Cancer, suggesting it targets the EGFR kinase pathway. The drug is being evaluated in combination with carotuximab.

Who makes Osimertinib?

Osimertinib is being developed by Kairos Pharma, Ltd., a company listed under the ticker symbol KAPA. The company is conducting a Phase 1 clinical trial of the drug for Non Small Cell Lung Cancer. Kairos Pharma is the sponsor of the ongoing study.

What phase is Osimertinib in?

Osimertinib is currently in Phase 1 clinical development. It is an investigational drug being studied for Non Small Cell Lung Cancer and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants in the United States.

What clinical trials is Osimertinib in?

Osimertinib is being evaluated in a Phase 1 clinical trial with the identifier NCT05401110, titled 'Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer.' The trial is recruiting 60 participants in the United States and is open to individuals aged 18 years and older.

Is Osimertinib the same as Tagrisso?

Osimertinib is the generic name for the drug also known as Tagrisso. In the context of this development program, Kairos Pharma is studying osimertinib in combination with carotuximab for EGFR-mutated Non Small Cell Lung Cancer. The drug is being evaluated in a Phase 1 clinical trial.