Double-Drug attack on lung cancer shows early promise
NCT ID NCT03810807
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested the safety of combining two targeted drugs, dacomitinib and osimertinib, in 22 people with a specific type of advanced lung cancer (EGFR mutant). Participants had not received similar targeted therapy before. The goal was to find the safest dose and see how well the combination shrinks tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
22 people
The number who actually took part.
- Started
-
Jan 2019
- Finished
-
Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Written informed consent * Advanced biopsy-proven metastatic non-small cell lung cancer * Somatic activating mutation in EGFR in a tumor biopsy * No prior EGFR inhibitor treatment (gefitinib, afatinib, erlotinib, dacomitinib, osimertinib) however, prior treatment with other chemotherapies are allowed * Archival tissue available from a pre-treatment tumor biopsy or willing to undergo a tumor biopsy prior to study initiation. * Measurable (RECIST 1.1) indicator lesion not previously irradiated * Karnofsky performance status (KPS) ≥ 70% * Age \>18 years old * Ability to swallow oral medication * Agree to use effective methods of contraception from the time of screening until 3 months after treatment discontinuation (for males and females of child-bearing potential) * Adequate organ function * AST, ALT ≤ 3 x ULN * Total bilirubin ≤1.5x ULN * Creatinine ≤ 1.5x ULN OR calculated creatinine clearance ≥ 60ml/min * Absolute neutrophil count (ANC) ≥ 1000 cells/mm\^3 * Hemoglobin≥9.0 g/dL * Platelets ≥100,000/mm\^3 Exclusion Criteria: * Pregnant or lactating women * Any radiotherapy within 1 week of starting treatment on protocol. * Any major surgery within 1 weeks of starting treatment on protocol. * Any evidence of active clinically significant interstitial lung disease * A mean QTc \>470ms (Fridericia"s correction), clinically important arrhythmia, conduction or morphology of resting ECG (eg complete LBBB, 1st -3rd degree heart block, any factors that increase the risk of QTc prolongation or risk of arrhythmia) * Cardiovascular disease or cerebrovascular disease, CVA or MI \< 6 months prior to study enrollment, unstable angina, NYHA \>Grade II CHF, or serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment * History of pneumonitis or interstitial lung disease (ILD), drug induced ILD, radiation pneumonitits that required steroid treatment, and any evidence of clinically active ILD * Serious chronic GI conditions associated with diarrhea * Symptomatic, unstable brain metastases requiring escalating doses of steroids * Continue to have unresolved \> CTCAE grade 1 toxicity from any previous treatment
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic non-small cell lung cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
-
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
-
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
-
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
-
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
-
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can radiation turn tumors into targets for immunotherapy?
- Seeing the fight: new imaging tracer may reveal how immune cells attack lung cancer
- Can a pill outperform chemo for a Hard-to-Treat lung cancer mutation?
- Can a new drug shrink Hard-to-Treat tumors?
- Breath test may reveal who benefits from lung cancer immunotherapy
- Targeted radiation and immunotherapy join forces against Hard-to-Treat lung cancer