EGFR L858R

Clinical trials

Active trials (430)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 206 recruiting · 121 active phase 3 · 1,570 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 430 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04487080	A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer(MARIPOSA)	active not recruiting

Literature

Linked publications (41)

Publications linked to the scope variant(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–25 of 41 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.
· N Engl J Med · 2017 · PMID 27959700 · validated civic_curation pubmed
U.S. Food and Drug Administration approval summary: Erlotinib for the first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations.
· Oncologist · 2014 · PMID 24868098 · validated civic_curation pubmed
Afatinib: first global approval.
· Drugs · 2013 · PMID 23982599 · validated civic_curation pubmed
Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer.
· N Engl J Med · 2020 · PMID 32955177 · validated

EGFR Exon 19 Deletion + EGFR L858R10

Erlotinib

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID3791

The phase 3 (EURTAC) study consisted of of 173 non-small cell lung cancer patients who had not had prior chemotherapy for metastatic disease (although adjuvant or neoadjuvant chemotherapy was permitte… (full text at CIViC)

PMID 22285168 · Rosell et al., 2012 · Open in CIViC

Amivantamab + Carboplatin + PemetrexedCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID12156

In this phase III trial, 657 patients with locally advanced or metastatic NSCLC (Non-Small Cell Lung Cancer) harbouring EGFR mutations (exon 19 deletions or L858R) were treated with amivantamab plus c… (full text at CIViC)

PMID 37879444 · Passaro et al., 2024 · Open in CIViC

Amivantamab + LazertinibCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID12131

In this trial (MARIPOSA), 1074 patients with Non-Small Cell Lung Cancer harbouring exon 19 deletion or exon 21 L858R substitution were randomized (2:2:1) to receive lazertinib-amivantamab (n=429), osi… (full text at CIViC)

PMID 38942080 · Felip et al., 2024 · Open in CIViC

Dacomitinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11239

In this phase 3, open-label, randomized trial, 452 patients with EGFR mutation-positive non-small cell lung cancer including exon 19 deletions and exon 21 L858R point mutations were randomized into co… (full text at CIViC)

PMID 28958502 · Wu et al., 2017 · Open in CIViC

Erlotinib + GefitinibSubstitutes

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID4759

In a study of 1261 non-small cell lung cancer patients, 49.8% of the analyzed tumors had EGFR mutations including deletions in exon 19 (n=258), L858R (n=260), T790M (n=6) and insertions or duplication… (full text at CIViC)

PMID 21531810 · Wu et al., 2011 · Open in CIViC

Erlotinib + RamucirumabCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11240

In this phase 3, randomized, double-blind, placebo-controlled trial, 449 patients stage IV NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations. Patients were randomly assigned in a 1:1 rati… (full text at CIViC)

PMID 31591063 · Nakagawa et al., 2019 · Open in CIViC

Gefitinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11241

In this phase-IV, open-label, single-arm study, 106 patients with NSCLC and EGFR mutations including exon 19 deletion and exon 21 L858R point mutations were administered 250 mg daily doses of gefitini… (full text at CIViC)

PMID 24263064 · Douillard et al., 2014 · Open in CIViC

〃

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID2156

A phase 2 study of 120 stage IIIB-IV lung adenocarcinoma patients reported improved progression free survival in patients with EGFR mutation (defined as exon 19 deletion or exon 21 mutation) when trea… (full text at CIViC)

PMID 24755888 · Yu et al., 2014 · Open in CIViC

Osimertinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11219

In this phase 3, double-blind trial, 682 patients were randomly assigned 1:1 to either osimertinib (80 mg once daily) or placebo for 3 years following complete resection of EGFR mutation positive (exo… (full text at CIViC)

PMID 32955177 · Wu et al., 2020 · Open in CIViC

Chemotherapy + OsimertinibCombination

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID12015

In this phase 3 clinical trial, 557 patients with NSCLC harbouring EGFR mutations (exon 19 deletion or L858R mutation) were randomly assigned to two groups and treated with either osimertinib with che… (full text at CIViC)

PMID 37937763 · Planchard et al., 2023 · Open in CIViC

EGFR L858R + EGFR T790M1

Osimertinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11599

This phase 3 trial (NCT02151981) involved 419 patients with EGFR T790M mutant NSCLC who progressed after first-line EGFR inhibitor therapy (gefitinib, erlotinib, or afatinib) and were either treated w… (full text at CIViC)

PMID 27959700 · Mok et al., 2017 · Open in CIViC

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

CA Health Canada

—

Marketed in Canada as MAR-AFATINIB (DIN 02517019) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 31, 2025

CA Health Canada

—

Marketed in Canada as MAR-AFATINIB (DIN 02517027) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 31, 2025

CA Health Canada

—

Marketed in Canada as MAR-AFATINIB (DIN 02517035) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 31, 2025

CA Health Canada

—

Marketed in Canada as SANDOZ AFATINIB (DIN 02512793) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Oct 28, 2024

CA Health Canada

—

Marketed in Canada as SANDOZ AFATINIB (DIN 02512785) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Oct 28, 2024

CA Health Canada

—

Marketed in Canada as SANDOZ AFATINIB (DIN 02512777) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Oct 28, 2024

CA Health Canada

—

Marketed in Canada as GIOTRIF (DIN 02415666) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 17, 2014

CA Health Canada

—

Marketed in Canada as GIOTRIF (DIN 02415674) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 17, 2014

CA Health Canada

—

Marketed in Canada as GIOTRIF (DIN 02415682) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 17, 2014

CA Health Canada

—

Marketed in Canada as TEVA-AFATINIB (DIN 02514591) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025

—

CA Health Canada

—

Marketed in Canada as TEVA-AFATINIB (DIN 02514605) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025

—

CA Health Canada

—

Marketed in Canada as TEVA-AFATINIB (DIN 02514613) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Apr 9, 2025

—

Lung Non-Small Cell Carcinoma

EU EMA

Giotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.

approved

Sep 25, 2013

ema