18 and older, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
9 Months Progression Free RatePrimary· 9 months
The percentage of participants that are free from objective disease progression or death at 9 months after the start treatment. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also
Group
Value
95% CI
EGF816 + Gefitinib
7
Overall Response Rate (ORR)Secondary· 4 years and 4 months
The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
* Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
* Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
All CRs and PRs must be confirmed by a second assessment not earlier than 4 weeks after the criter
Group
Value
95% CI
EGF816 + Gefitinib
8
Median Overall SurvivalSecondary· 6 years
Overall survival is defined as time from the start of treatment until death or loss to follow up. Overall survival will be analyzed using the Kaplan-Meier method.
Group
Value
95% CI
EGF816 + Gefitinib
35.7
6.18 – NA
Median Progression Free Survival (PFS)Secondary· 4.2 years
PFS is defined as the time from start of treatment to the time of objective disease progression, death, or loss to follow up. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also co
Group
Value
95% CI
EGF816 + Gefitinib
20.86
5.42 – 39.57
Summary of Treatment-related Adverse EventsSecondary· Start of treatment through 30 days after the end of treatment (max 4 years and 5 months)
Treatment-related adverse events, defined as those at least possibly related to study treatment, are summarized below as a measure of patient safety and treatment tolerability. Subjects were evaluated for adverse events by the Common Terminology Criteria for Adverse Events (CTCAE) v4. For each treatment-related event, subjects are counted below by the highest grade they experienced on study per CTCAE v 4.0 to demonstrate the range and severity of treatment-related toxicities documented on study. Grade refers to the severity of the toxicity, with Grade 1 corresponding to mild toxicity, Grade 2
Anemia
Group
Value
95% CI
EGF816 + Gefitinib
1
EGF816 + Gefitinib
0
EGF816 + Gefitinib
0
EGF816 + Gefitinib
10
Cardiac disorders - other, specify
Group
Value
95% CI
EGF816 + Gefitinib
0
EGF816 + Gefitinib
1
EGF816 + Gefitinib
0
EGF816 + Gefitinib
10
Dry eye
Group
Value
95% CI
EGF816 + Gefitinib
1
EGF816 + Gefitinib
0
EGF816 + Gefitinib
0
EGF816 + Gefitinib
10
Eye Pain
Group
Value
95% CI
EGF816 + Gefitinib
1
EGF816 + Gefitinib
0
EGF816 + Gefitinib
0
EGF816 + Gefitinib
10
Abdominal Pain
Group
Value
95% CI
EGF816 + Gefitinib
1
EGF816 + Gefitinib
0
EGF816 + Gefitinib
0
EGF816 + Gefitinib
10
Bloating
Group
Value
95% CI
EGF816 + Gefitinib
1
EGF816 + Gefitinib
0
EGF816 + Gefitinib
0
EGF816 + Gefitinib
10
Diarrhea
Group
Value
95% CI
EGF816 + Gefitinib
6
EGF816 + Gefitinib
3
EGF816 + Gefitinib
2
EGF816 + Gefitinib
0
Dry mouth
Group
Value
95% CI
EGF816 + Gefitinib
3
EGF816 + Gefitinib
0
EGF816 + Gefitinib
0
EGF816 + Gefitinib
8
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events are collected from informed consent until 30 days after the end of treatment (maximum 4 years and 5 months). Patients were monitored for survival up to 6 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
EGF816 + Gefitinib
Serious: 2/11 (18%)
Deaths: 4/11
Serious adverse events (2 terms)
Reaction
System
EGF816 + Gefitinib
Fever
General disorders
—
Pericardial effusion
Cardiac disorders
—
Other adverse events (104 terms — click to expand)
This research study is studying a combination of drugs as a possible treatment for EGFR mutation-positive lung cancer.
The drugs involved in this study are:
* EGF816
* Gefitinib
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03516214 — EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations
· Phase 1
· completed
NCT03333343 — Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
· Phase 1
· active not recruiting
NCT02900664 — A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)
· Phase 1
· completed
NCT02323126 — Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Pati
· Phase 2
· terminated
NCT02108964 — A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut So
· Phase 1, PHASE2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 10 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03292133.