A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03567642
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Osimertinib 80mg daily
  • Platinum — DRUG
    Cisplatin 60mg/m2 or Cisplatin 45mg/m2 Carboplatin AUC 5 or Carboplatin AUC 4
  • Etoposide — DRUG
    Etoposide 100mg/m2 or Etoposide 80mg/m2

Study Details

The purpose of this study is to test the safety of combining Osimertinib with either Cisplatin or Carboplatin (at different dose levels) and Etoposide, to find out what effects, if any, this combination of drugs has on people with EGFR mutant lung cancer.

Key Dates

Start date
Jun 12, 2018
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Osimertinib, Platinum (cisplatin or carboplatin) and Etoposide
    Initially, 6 patients will be enrolled and will begin treatment with osimertinib 80mg orally daily (3 who will be receiving cisplatin and 3 who will be receiving carboplatin). Cisplatin or carboplatin treatment will be decided by the treating physician prior to study registration. After 9 weeks (+/- 1 week)( 3 cycles) on osimertinib alone, carboplatin or cisplatin and etoposide will be added. Carboplatin is doses at an AUC of 5 or cisplatin at 60mg/m2 will be given on C4D1. Etoposide is dosed at 100mg/m2 given on Days 1-3 of C4. Only patients on osimertinib 80mg orally daily at the start of cycle 4 will be included in the 3+3 dose de-escalation portion of the study. Chemotherapy and osimertinib will be administered concurrently during cycles 4-7, and from cycle 8 onward, osimertinib monotherapy will be continued. Patients will present every 2 cycles post-chemo (Cycles 8, 10, 12, etc.)

Primary Outcome Measure

The MTD (maximum tolerated dose) [ Time Frame: 2 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauUniondaleNew York11553-

Find similar trials in Basking Ridge, NJ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Memorial Sloan Kettering Cancer Center· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJMemorial Sloan Kettering Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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