CSMC, IIT2021-12-Reckamp-Osi105, Ph1, open label, EGFR-mutated NSCLC, Osimertinib and Carotuximab.

Summary

Primary Objectives Determine safety and recommended phase 2 dose (RP2D) of combination osimertinib + carotuximab in patients with EGFR mutant NSCLC Secondary Objectives To evaluate the response rate (RR), duration of response (DoR), progression free survival (PFS), and disease control rate (DCR) of patients treated with osimertinib and carotuximab in patients with EGFR mutant NSCLC, 1) post osimertinib or other EGFR TKI therapy; 2) with persistent ctDNA after 6-12 weeks on osimertinib. To assess biomarkers of response and resistance to the combination with tumor tissue and serial circulating DNA (ctDNA) for mutations


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.
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Study Location(s)

Cedars-Sinai Cancer at Hunt Cancer Center - TMPNCC (CSMC Affiliate)

More about this Clinical Trial

Full Title

IIT2021-12-Reckamp-Osi105: Phase 1 Study of Osimertinib with Carotuximab in Advanced, EGFR-mutated Non-small Cell Lung Cancer

Details
Disease Type/Condition

Lung

Principal Investigator

Reckamp, Karen

Co-Investigators

Alain Mita, Andrew Horodner, Cathie T Chung, Edwin Posadas, Inderjit Mehmi, Jeremy Lorber, Kevin Scher, Kristopher Wentzel, Neil Bhowmick, Omid Hamid, Rodolfo Gutierrez, Sukhmani Padda, Vi K. Chiu

Age Group

Adult

Phase

I

IRB Number

STUDY00002130

ClinicalTrials.gov ID

NCT05401110

Key Eligibility
ClinicalTrials.gov

Contact
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Lung

Principal Investigator

Reckamp, Karen

Age Group

Adult

Phase

I

IRB Number

IIT2021-12-RECKAMP-OSI105

ClinicalTrials.gov ID

NCT05401110

Key Eligibility
ClinicalTrials.gov

Contact
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org
Want to join the study or
learn more?