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    BIOMARKER:

    EGFR exon 19 deletion + EGFR L861Q

    i
    Other names: EGFR, ERBB, ERBB1, Epidermal growth factor receptor
    Entrez ID:
    1956
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    3ms
    NCI-2021-04325: Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    EGFR mutation • BRAF mutation • BRAF V600 • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q • EGFR T790M negative
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    3ms
    Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC (clinicaltrials.gov)
    P1, N=52, Completed, AstraZeneca | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jun 2024
    Trial completion • Trial completion date
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib) • simvastatin
    7ms
    U31402-A-U102: HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=309, Recruiting, Daiichi Sankyo | Active, not recruiting --> Recruiting | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Jan 2022 --> Mar 2026
    Enrollment open • Trial completion date • Trial primary completion date • Metastases
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR L861Q • ROS1 fusion • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q • ALK-ROS1 fusion
    |
    patritumab deruxtecan (U3-1402)
    10ms
    Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC (clinicaltrials.gov)
    P1, N=52, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib)
    10ms
    Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=50, Active, not recruiting, National Cancer Institute (NCI) | Phase classification: P1b --> P1
    Phase classification • Combination therapy • Metastases
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR positive • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib) • navitoclax (ABT 263)
    11ms
    An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=59, Active, not recruiting, Incyte Corporation | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib) • itacitinib (INCB039110)
    11ms
    AURA: AZD9291 First Time In Patients Ascending Dose Study (clinicaltrials.gov)
    P1/2, N=603, Completed, AstraZeneca | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib)
    1year
    AURA2: Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours (clinicaltrials.gov)
    P2, N=210, Completed, AstraZeneca | Active, not recruiting --> Completed
    Trial completion
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib)
    1year
    Balise: A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations (clinicaltrials.gov)
    P2, N=150, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    erlotinib • emibetuzumab (LY2875358)
    1year
    NCI-2021-04325: Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=55 --> 35
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    EGFR mutation • BRAF mutation • BRAF V600 • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q • EGFR T790M negative
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    1year
    NCI-2021-04325: Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=55, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    EGFR mutation • BRAF mutation • BRAF V600 • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q • EGFR T790M negative
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    1year
    U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=271, Active, not recruiting, Daiichi Sankyo, Inc. | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR L861Q • ROS1 fusion • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q • ALK-ROS1 fusion
    |
    patritumab deruxtecan (U3-1402)
    over1year
    Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1b, N=50, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Jul 2024
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BCL2 (B-cell CLL/lymphoma 2) • BCL2L1 (BCL2-like 1) • BCL2L11 (BCL2 Like 11)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR positive • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib) • navitoclax (ABT 263)
    over1year
    EGFR exon 19 insertion EGFR-K745_E746insIPVAIK and others with rare XPVAIK amino-acid insertions: Preclinical and clinical characterization of the favorable therapeutic window to all classes of approved EGFR kinase inhibitors. (PubMed, Lung Cancer)
    This is the largest preclinical/clinical report to highlight that EGFR-K745_E746insIPVAIK and other mutations with exon 19 XPVAIK amino-acid insertions are rare but sensitive to clinically available 1st, 2nd, and 3rd generation as well as EGFR exon 20 active TKIs; in a pattern that mostly resembles the outcomes of models with EGFR-L861Q and EGFR-A763_Y764insFQEA mutations. These data may help with the off-label selection of EGFR TKIs and clinical expectations of outcomes when targeted therapy is deployed for these EGFR mutated lung cancers.
    Preclinical • Journal
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR L861Q • EGFR A763_Y764insFQEA • EGFR exon 20 mutation • EGFR G719S • EGFR exon 19 deletion + EGFR L861Q • EGFR exon 19 insertion • EGFR E746
    |
    Tagrisso (osimertinib) • erlotinib • Gilotrif (afatinib) • gefitinib • Conmana (icotinib) • Exkivity (mobocertinib)
    over1year
    Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva) (clinicaltrials.gov)
    P1, N=39, Completed, AstraZeneca | Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> May 2023
    Trial completion • Trial completion date
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib) • erlotinib • gefitinib • itraconazole
    over1year
    NCI-2021-04325: Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=55, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    EGFR mutation • BRAF mutation • BRAF V600 • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q • EGFR T790M negative
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    almost2years
    An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=59, Active, not recruiting, Incyte Corporation | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib) • itacitinib (INCB039110)
    almost2years
    U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=271, Active, not recruiting, Daiichi Sankyo, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR L861Q • ROS1 fusion • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q • ALK-ROS1 fusion
    |
    patritumab deruxtecan (U3-1402)
    almost2years
    AURA: AZD9291 First Time In Patients Ascending Dose Study (clinicaltrials.gov)
    P1/2, N=603, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2022 --> Dec 2023
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib)
    almost2years
    Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=38, Completed, AstraZeneca | Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Jan 2023
    Trial completion • Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib)
    almost2years
    APOLLO: A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC (clinicaltrials.gov)
    P1/2, N=364, Active, not recruiting, Jiangsu Hansoh Pharmaceutical Co., Ltd. | Trial completion date: Nov 2022 --> Mar 2023
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Ameile (aumolertinib)
    almost2years
    Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=38, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2022 --> Jun 2023
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib)
    almost2years
    Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC (clinicaltrials.gov)
    P1, N=52, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2022 --> Dec 2023
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib) • simvastatin
    almost2years
    Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva) (clinicaltrials.gov)
    P1, N=39, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2022 --> Dec 2023
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib) • erlotinib • gefitinib • itraconazole
    2years
    Balise: A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations (clinicaltrials.gov)
    P2, N=150, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2022 --> Dec 2023
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    |
    erlotinib • emibetuzumab (LY2875358)
    over2years
    Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC (clinicaltrials.gov)
    P2, N=180, Recruiting, Guangdong Association of Clinical Trials | Not yet recruiting --> Recruiting
    Enrollment open • Minimal residual disease
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    over2years
    Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC (clinicaltrials.gov)
    P2, N=180, Not yet recruiting, Guangdong Association of Clinical Trials
    New P2 trial • Minimal residual disease
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q
    over2years
    Sensitivity analysis of EGFR L861Q mutation to six tyrosine kinase inhibitors. (PubMed, Clin Transl Oncol)
    Based on the above results, EGFR L861Q + 19del variant and EGFR L861Q variant showed significant sensitivity to six first-in-class TKIs. Among the six TKIs, the first generation TKIs (gefitinib/erlotinib/icotinib), showed stronger inhibition ability to the EGFR L861Q + 19del variant and EGFR L861Q variant, among which gefitinib showed the strongest inhibition.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ANXA5 (Annexin A5)
    |
    EGFR mutation • EGFR exon 19 deletion • EGFR L861Q • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib) • erlotinib • Gilotrif (afatinib) • gefitinib • Conmana (icotinib) • Vizimpro (dacomitinib)
    over2years
    Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1b, N=50, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: Jul 2022 --> Jul 2023
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • BCL2 (B-cell CLL/lymphoma 2) • BCL2L1 (BCL2-like 1) • BCL2L11 (BCL2 Like 11)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR positive • EGFR exon 19 deletion + EGFR L861Q
    |
    Tagrisso (osimertinib) • navitoclax (ABT 263)
    over2years
    U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=264, Recruiting, Daiichi Sankyo, Inc. | Active, not recruiting --> Recruiting
    Enrollment open
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR L861Q • ROS1 fusion • EGFR G719X • EGFR exon 19 deletion + EGFR L861Q • ALK-ROS1 fusion
    |
    patritumab deruxtecan (U3-1402)