NCT03392246

A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

Active, enrolled Phase 2 Last updated 22 January 2026

What this trial tests

Phase 2 trial testing Osimertinib in Non-small Cell Lung Cancer in 25 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 January 2018

Primary endpoint
30 June 2026

30 December 2026

Quick facts

Lead sponsor	Dana-Farber Cancer Institute
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	31 January 2018
Primary completion	30 June 2026
Estimated completion	30 December 2026
Sites	4 locations across United States

Drugs / interventions tested

• Osimertinib (osimertinib) — full drug profile →
• Selumetinib — full drug profile →

Conditions studied

• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Dana-Farber Cancer Institute

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research study is studying a combination of two targeted therapies as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation.

The drugs involved in this study are:

* Osimertinib (Tagrisso)
* Selumetinib

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Resistance mechanisms to osimertinib in EGFR-mutated non-small cell lung cancer.
   Leonetti A, Sharma S, Minari R, Perego P, et al · · 2019 · cited 1098× · PMID 31564718 · DOI 10.1038/s41416-019-0573-8
2. Treatment-Induced Tumor Dormancy through YAP-Mediated Transcriptional Reprogramming of the Apoptotic Pathway.
   Kurppa KJ, Liu Y, To C, Zhang T, et al · · 2020 · cited 403× · PMID 31935369 · DOI 10.1016/j.ccell.2019.12.006
3. Therapeutic strategies for EGFR-mutated non-small cell lung cancer patients with osimertinib resistance.
   Fu K, Xie F, Wang F, Fu L. · · 2022 · cited 271× · PMID 36482474 · DOI 10.1186/s13045-022-01391-4
4. Targeted therapy in advanced non-small cell lung cancer: current advances and future trends.
   Majeed U, Manochakian R, Zhao Y, Lou Y. · · 2021 · cited 193× · PMID 34238332 · DOI 10.1186/s13045-021-01121-2
5. Clonal Evolution and Heterogeneity of Osimertinib Acquired Resistance Mechanisms in EGFR Mutant Lung Cancer.
   Roper N, Brown AL, Wei JS, Pack S, et al · · 2020 · cited 135× · PMID 32483558 · DOI 10.1016/j.xcrm.2020.100007
6. Development of EGFR TKIs and Options to Manage Resistance of Third-Generation EGFR TKI Osimertinib: Conventional Ways and Immune Checkpoint Inhibitors.
   Wu L, Ke L, Zhang Z, Yu J, et al · · 2020 · cited 77× · PMID 33392095 · DOI 10.3389/fonc.2020.602762
7. Third-generation epidermal growth factor receptor tyrosine kinase inhibitors for the treatment of non-small cell lung cancer.
   Andrews Wright NM, Goss GD. · · 2019 · cited 66× · PMID 31857949 · DOI 10.21037/tlcr.2019.06.01
8. Marked synergy by vertical inhibition of EGFR signaling in NSCLC spheroids shows SOS1 is a therapeutic target in EGFR-mutated cancer.
   Theard PL, Sheffels E, Sealover NE, Linke AJ, et al · · 2020 · cited 55× · PMID 32897190 · DOI 10.7554/elife.58204