A Phase 1 interventional study of EGF816 and trametinib in EGFR-mutant Non-small Cell Lung Cancer, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 11 sites in 6 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 1, Interventional, and Treatment
Among 95 studies in Carcinoma, Non-Small-Cell Lung by Novartis Pharmaceuticals — 8 open to participants now, 15 under way, none of them phase 3. Carcinoma, Non-Small-Cell Lung · Novartis Pharmaceuticals.
Among the 95 studies in Carcinoma, Non-Small-Cell Lung by Novartis Pharmaceuticals, this one is the 39th largest by enrollment of the 86 interventional ones that give a count, is one of 9 that started in 2018, is one of 33 in phase 1, reaches primary completion later than 4 of the 14 other live ones, and was the 53rd registered.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →8 of the 95 studies in Carcinoma, Non-Small-Cell Lung by Novartis Pharmaceuticals are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Australia, Japan
Novartis Pharmaceuticals · Sites in Netherlands
Novartis Pharmaceuticals · Sites in Denmark, Japan
Novartis Pharmaceuticals · Sites in United States, Australia, Canada and 1 more country
Novartis Pharmaceuticals · Sites in United States, Canada, Denmark and 4 more countries
By country, each count listing its studies:
Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
95 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 43 · Phase 2 36 · Phase 3 14 · Phase 4 3
First in 1998; this study’s year is marked. 9 started in 2018.
This study's enrollment of 105 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 92 across the 86 interventional studies, 109 across the 5 observational. Of the 71 that completed or were terminated, 38 (54%) have results posted.
This tab as a report to print or save as PDF → With an account.
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
6 of the studies in Carcinoma, Non-Small-Cell Lung by Novartis Pharmaceuticals that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04699188Novartis PharmaceuticalsStudy of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation | 2027-01-25 |
| NCT02393625Novartis PharmaceuticalsStudy of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer | 2027-04-09 |
| NCT03891953Novartis PharmaceuticalsStudy of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. | 2027-06-25 |
| NCT03333343Novartis PharmaceuticalsStudy of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC | 2027-07-12 |
| NCT03040973Novartis PharmaceuticalsStudy to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone | 2027-07-30 |
Among the 95 studies in Carcinoma, Non-Small-Cell Lung by Novartis Pharmaceuticals, from their registry updates:
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The study purpose is to evaluate the safety, tolerability, and preliminary efficacy of the addition of INC280, trametinib, ribociclib, gefitinib, or LXH254 to EGF816 in adult patients with advanced Epidermal growth factor receptor- mutant (EGFR-mutant) non-small cell lung cancer (NSCLC).
This is a Phase Ib, open label, non-randomized dose escalation study of EGF816 in combination with ribociclib, trametinib, or LXH254, followed by dose expansion of EGF816 in combination with ribociclib, trametinib, LXH254, INC280, or gefitinib in adult patients with advanced EGFR-mutant NSCLC.
During the dose escalation part, patients were assigned to the addition of trametinib, ribociclib, or LXH254 to EGF816.
Following determination of the recommended dose for the combination of EGF816 + trametinib, EGF816 + ribociclib, and EGF816 + LXH254, patients could be enrolled to the dose expansion arms of each of these combinations. Patients could also be assigned to EGF816 + INC280. The planned arm EGF816 + gefitinib in dose expansion was not opened for enrollment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who have been treated with systemic anti-neoplastic therapy within:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EGF816+ trametinib in escalation phase
Drug: EGF816 · Drug: trametinib
EGF816 + ribociclib in escalation phase
Drug: EGF816 · Drug: ribociclib
EGF816 + LXH254 in escalation phase
Drug: EGF816 · Drug: LXH254
EGF816 + INC280 in expansion phase (patients with no known resistance mechanism)
Drug: EGF816 · Drug: INC280
EGF816 + trametinib in expansion phase
Drug: EGF816 · Drug: trametinib
EGF816 + ribociclib in expansion phase
Drug: EGF816 · Drug: ribociclib
EGF816 + LXH254 in expansion phase (patients with no known resistance mechanism)
Drug: EGF816 · Drug: LXH254
EGF816 + LXH254 in expansion phase (patients with known resistance mechanism)
Drug: EGF816 · Drug: LXH254
EGF816 + gefitinib in expansion phase
Drug: EGF816 · Drug: gefitinib
EGF816 + INC280 in expansion phase (patients with known resistance mechanism)
Drug: EGF816 · Drug: INC280
Study Drug
Study Drug
Study Drug
Study Drug
Study Drug
Study Drug
Number of patients with adverse events and serious adverse events
Assess safety and tolerability including incidence of dose limiting toxicities, adverse events, and serious adverse events.
Time frame: Every day until study end, approximately 4 years
Number of participants with DLTs in the first cycle of combination (Dose escalation only)
A Dose-Limiting Toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 28 days of combination treatment during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Time frame: 28 days
Number of participants with dose interruptions and reductions
Assessment of tolerability. For patients who do not tolerate the protocol-specified dosing schedule, dose adjustments may be permitted in order to allow patients to continue the study treatment.
Time frame: From first dose until study ends, approximately 4 years
Dose intensity of study drugs
Dose intensity is computed as the ratio of actual cumulative dose received to actual duration of exposure.
Time frame: From first dose until study ends, approximately 4 years
ORR2
Modified objective response rate (ORR2) per RECIST v1.1 (taking as baseline the most recent assessment prior to initiating combination)
Time frame: Every 8-12 weeks until study ends, approximately 4 years
ORR
Overall response rate (ORR) per RECIST v1.1
Time frame: Every 8-12 weeks until study ends, approximately 4 years
PFS
Time from the date of first dose of study treatment to the date of first documented disease progression (per RECIST v1.1) or death due to any cause
Time frame: Every 8-12 weeks until study ends, approximately 4 years
DCR
Proportion of patients with best overall response of CR, PR, or SD
Time frame: Every 8-12 weeks until study ends, approximately 4 years
DOR
Time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause
Time frame: Every 8-12 weeks until study ends, approximately 4 years
Time to response
Time to response is the time between start of treatment until first documented response per RECIST v1.1.
Time frame: Every 8-12 weeks until study ends, approximately 4 years
Area under the plasma concentration-time curve (AUC) of study drugs
Pharmacokinetic (PK) parameters calculated based on the plasma concentrations versus time profiles by using non-compartmental methods.
Time frame: From pre-dose up to 8 hours post-dose on Day 15 of Cycle 1. One cycle=28 days.
Maximum observed plasma concentration (Cmax) of study drugs
PK parameters calculated based on the plasma concentrations versus time profiles by using non-compartmental methods.
Time frame: From pre-dose up to 8 hours post-dose on Day 15 of Cycle 1. One cycle=28 days.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2018 (actual). Primary completion is estimated for Jul 2027, 113 months after the start.
Of 473 industry-sponsored phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's planned 113 months is above that.
Counting every sponsor, half of 699 studies reached it within 50 months; a quarter within 31 and three quarters within 70.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: primary completion Oct 2026 → Jul 2027 and completion Oct 2026 → Jul 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →