SNPMiner Trials by Shray Alag

NCT00511368 (37) NCT00460382 (36) NCT04504071 (35) NCT03783286 (33) NCT04172597 (32) NCT02404233 (29) NCT00959894 (28) NCT00706147 (28) NCT00121017 (28) NCT01685801 (27) NCT04513626 (26) NCT01736761 (26) NCT04495348 (24) NCT02673398 (23) NCT02499978 (22) NCT01605084 (21) NCT04254705 (21) NCT02069834 (21) NCT00939770 (18) NCT01792570 (18) NCT01199939 (18) NCT00356616 (18) NCT02728258 (17) NCT02707601 (17) NCT02770508 (16) NCT00711009 (16) NCT00630864 (16) NCT00491556 (15) NCT04085315 (15) NCT02616029 (15) NCT00830804 (15) NCT04681820 (15) NCT01170962 (14) NCT00984152 (14) NCT03953898 (14) NCT00727597 (14) NCT03212274 (14) NCT01369199 (13) NCT00337467 (13) NCT00098293 (13) NCT01368497 (13) NCT02159599 (13) NCT00424814 (12) NCT04432454 (12) NCT02527096 (12) NCT01849003 (12) NCT03781063 (12) NCT03683524 (11) NCT01614457 (11) NCT00460746 (11) NCT00993148 (11) NCT03061331 (11) NCT02494882 (11) NCT03068312 (11) NCT04453436 (11) NCT01521338 (10) NCT02725567 (10) NCT01614470 (10) NCT01423812 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NCT02554591 (5) NCT01501604 (5) NCT02716116 (5) NCT01136460 (5) NCT00187655 (5) NCT00350272 (5) NCT00837135 (5) NCT03202862 (5) NCT01707199 (5) NCT03839342 (5) NCT01323010 (4) NCT02248324 (4) NCT01698905 (4) NCT01737359 (4) NCT01306045 (4) NCT02804100 (4) NCT01456676 (4) NCT00588172 (4) NCT03434418 (4) NCT03593993 (4) NCT01804140 (4) NCT02882308 (4) NCT03497767 (4) NCT04106024 (4) NCT02716311 (4) NCT04405674 (4) NCT03599518 (4) NCT01675778 (4) NCT01604122 (4) NCT01297777 (4) NCT04519970 (4) NCT00705679 (4) NCT04147351 (4) NCT04129502 (4) NCT03976856 (4) NCT02335944 (4) NCT04625647 (4) NCT03948763 (4) NCT03255083 (4) NCT04002830 (4) NCT02635815 (4) NCT03066206 (4) NCT01331642 (4) NCT00557245 (4) NCT01922583 (4) NCT02893332 (4) NCT03592888 (4) NCT02257424 (4) NCT03874858 (4) NCT00017732 (4) NCT00187720 (4) NCT02593539 (4) NCT01185587 (4) NCT04439292 (4) NCT03884348 (4) NCT01309243 (4) NCT03209063 (4) NCT04160546 (4) NCT03292302 (4) NCT02418234 (4) NCT02535338 (3) NCT02192697 (3) NCT03410043 (3) NCT03845296 (3) NCT02914990 (3) NCT02113813 (3) NCT01532011 (3) NCT04340388 (3) NCT00962533 (3) NCT03856411 (3) NCT04049266 (3) NCT02973763 (3) NCT02926092 (3) NCT00271973 (3) NCT04256941 (3) NCT03812809 (3) NCT02954523 (3) NCT01784068 (3) NCT03446417 (3) NCT02841579 (3) NCT02025114 (3) NCT01288521 (3) NCT01385683 (3) NCT02279004 (3) NCT00998582 (3) NCT03111901 (3) NCT01352715 (3) NCT01619774 (3) NCT01045369 (3) NCT02246998 (3) NCT03969823 (3) NCT00895596 (3) NCT02398929 (3) NCT00724711 (3) NCT04029350 (3) NCT03737994 (3) NCT01443806 (3) NCT02629822 (3) NCT03463525 (3) NCT00710112 (3) NCT03623750 (3) NCT04283955 (3) NCT02743923 (3) NCT01016106 (3) NCT01259089 (3) NCT03971474 (3) NCT02917993 (3) NCT02368990 (3) NCT00279110 (3) NCT02485652 (3) NCT00312169 (3) NCT04541407 (3) NCT02769286 (3) NCT00747487 (3) NCT04267913 (3) NCT01429597 (3) NCT04023617 (3) NCT03790228 (3) NCT01759888 (3) NCT04429152 (3) NCT01810718 (3) NCT02725632 (3) NCT01090011 (3) NCT04544111 (3) NCT02926768 (3) NCT02981108 (3) NCT02459743 (3) NCT00654823 (3) NCT01037127 (3) NCT04439305 (3) NCT01028222 (3) NCT01542411 (3) NCT01031446 (3) NCT02726269 (3) NCT01892644 (3) NCT03260491 (3) NCT01802632 (3) NCT02720094 (3) NCT02630186 (3) NCT01627132 (3) NCT02690675 (3) NCT01013506 (3) NCT04252339 (3) NCT02496663 (3) NCT03386955 (3) NCT03394118 (3) NCT04212702 (3) NCT01754025 (3) NCT01160276 (3) NCT00121979 (3) NCT03228277 (3) NCT04351555 (3) NCT01243346 (3) NCT04510415 (3) NCT02796274 (3) NCT02774005 (3) NCT02064491 (3) NCT04233021 (3) NCT03799601 (3) NCT00260260 (3) NCT02094261 (3) NCT04245085 (3) NCT03058094 (3) NCT01282151 (3) NCT02520778 (3) NCT03161808 (3) NCT04181060 (3) NCT01342679 (3) NCT01443273 (3) NCT01593254 (3) NCT04433481 (3) NCT02529995 (3) NCT03502850 (3) NCT02771314 (3) NCT03823807 (3) NCT03270527 (3) NCT02688881 (3) NCT01005602 (3) NCT02442349 (3) NCT02684591 (2) NCT02282267 (2) NCT03381430 (2) NCT02178397 (2) NCT03608215 (2) NCT02603107 (2) NCT03370770 (2) NCT03322696 (2) NCT03333343 (2) NCT00525473 (2) NCT03127449 (2) NCT01781026 (2) NCT02503722 (2) NCT00975871 (2) NCT03964233 (2) NCT03388099 (2) NCT02317016 (2) NCT03845270 (2) NCT03519958 (2) NCT03918304 (2) NCT02151721 (2) NCT02777658 (2) NCT01016444 (2) NCT02971501 (2) NCT03101254 (2) NCT03178617 (2) NCT01774721 (2) NCT03574753 (2) NCT01357655 (2) NCT01766713 (2) NCT02097225 (2) NCT00658164 (2) NCT03622593 (2) NCT02571036 (2) NCT00969137 (2) NCT00834665 (2) NCT02026011 (2) NCT03622580 (2) NCT03543683 (2) NCT01143493 (2) NCT03671538 (2) NCT04028778 (2) NCT00324961 (2) NCT01915576 (2) NCT02157883 (2) NCT01387022 (2) NCT03864042 (2) NCT03235245 (2) NCT03469960 (2) NCT02795884 (2) NCT04687241 (2) NCT00005541 (2) NCT01242813 (2) NCT03960645 (2) NCT00643058 (2) NCT03443336 (2) NCT02992860 (2) NCT02281760 (2) NCT02201602 (2) NCT04310007 (2) NCT04309019 (2) NCT03720665 (2) NCT00909532 (2) NCT00411944 (2) NCT01604681 (2) NCT01245062 (2) NCT00270231 (2) NCT03256136 (2) NCT03973918 (2) NCT00302692 (2) NCT00125281 (2) NCT02163733 (2) NCT02110407 (2) NCT00475176 (2) NCT03196882 (2) NCT01572818 (2) NCT02556333 (2) NCT04268550 (2) NCT02433717 (2) NCT03428126 (2) NCT01153763 (2) NCT02609776 (2) NCT01420211 (2) NCT03556176 (2) NCT03872440 (2) NCT01405079 (2) NCT03382795 (2) NCT02991950 (2) NCT00013598 (2) NCT03455764 (2) NCT02422628 (2) NCT03831932 (2) NCT03766490 (2) NCT02580474 (2) NCT00499577 (2) NCT02444884 (2) NCT01775943 (2) NCT03544814 (2) NCT01310036 (2) NCT01027663 (2) NCT01928160 (2) NCT01244438 (2) NCT00007150 (2) NCT04462081 (2) NCT02297425 (2) NCT02086071 (2) NCT01050400 (2) NCT03060590 (2) NCT01819428 (2) NCT02709668 (2) NCT02411448 (2) NCT03878719 (2) NCT04622072 (2) NCT04479306 (2) NCT03377023 (2) NCT01378026 (2) NCT03239145 (2) NCT04511533 (2) NCT00226551 (2) NCT02191891 (2) NCT04586270 (2) NCT04669535 (2) NCT04545710 (2) NCT02120222 (2) NCT02738593 (2) NCT00831272 (2) NCT04469543 (2) NCT00573495 (2) NCT04158544 (2) NCT00904150 (2) NCT02110056 (2) NCT02856893 (2) NCT02110043 (2) NCT02182986 (2) NCT04179890 (2) NCT00063232 (2) NCT02197234 (2) NCT03121235 (2) NCT01532089 (2) NCT03887169 (2) NCT02268864 (2) NCT01963845 (2) NCT00866736 (2) NCT03991013 (2) NCT02500927 (2) NCT04657991 (2) NCT02228382 (2) NCT02689570 (2) NCT01513785 (2) NCT02463435 (2) NCT03351361 (2) NCT04527549 (2) NCT03424759 (2) NCT02197247 (2) NCT02321046 (2) NCT04272034 (2) NCT04646824 (2) NCT04027647 (2) NCT02364609 (2) NCT02759835 (2) NCT04349865 (2) NCT00068159 (2) NCT00418015 (2) NCT04310397 (2) NCT03088176 (2) NCT03867175 (2) NCT00339209 (2) NCT00011258 (2) NCT01288430 (2) NCT01616199 (2) NCT03603262 (2) NCT03071705 (2) NCT00969930 (2) NCT00772408 (2) NCT02743468 (2) NCT00277342 (2) NCT04248829 (2) NCT01767454 (2) NCT00933127 (2) NCT03317873 (2) NCT03392246 (2) NCT01909453 (2) NCT03523104 (2) NCT00085917 (2) NCT02507921 (2) NCT03781752 (2) NCT03828422 (2) NCT02193282 (2) NCT03195452 (2) NCT04657289 (2) NCT02294487 (2) NCT01325441 (2) NCT02511106 (2) NCT02997501 (2) NCT04184921 (2) NCT00625092 (2) NCT01657786 (2) NCT01415011 (2) NCT02629523 (2) NCT01718847 (2) NCT02818023 (2) NCT00577707 (2) NCT01943422 (2) NCT00116636 (2) NCT04429542 (2) NCT01841463 (2) NCT03865511 (2) NCT03205267 (2) NCT01218477 (2) NCT02881320 (2) NCT01897480 (2) NCT02810990 (2) NCT04189757 (2) NCT01951001 (2) NCT04254939 (2) NCT03207867 (2) NCT00780949 (2) NCT03355768 (2) NCT00817089 (2) NCT02143466 (2) NCT04499053 (2) NCT01907776 (2) NCT00909727 (2) NCT01562028 (2) NCT03737253 (2) NCT00441974 (2) NCT02155465 (2) NCT04586335 (2) NCT00661999 (2) NCT02705339 (2) NCT04006340 (2) NCT04553887 (2) NCT04645225 (2) NCT03852290 (2) NCT02183922 (2) NCT03970239 (2) NCT00294372 (2) NCT03250676 (2) NCT03792074 (2) NCT00671892 (2) NCT00689182 (2) NCT00106379 (2) NCT01947023 (2) NCT00509652 (2) NCT03683251 (2) NCT02039986 (2) NCT03515837 (2) NCT04081688 (2) NCT03190005 (2) NCT01584648 (2) NCT02292654 (2) NCT03992456 (2) NCT03133546 (2) NCT01485809 (2) NCT01266967 (2) NCT04644315 (2) NCT02909712 (2) NCT00062764 (2) NCT01776684 (2) NCT03042221 (2) NCT01940809 (2) NCT04675008 (2) NCT01161537 (2) NCT01154816 (2) NCT01175759 (2) NCT01199731 (2) NCT02788058 (2) NCT03130452 (2) NCT04687423 (2) NCT01772732 (2) NCT02631447 (2) NCT02525692 (2) NCT02526537 (2) NCT03513666 (2) NCT02027961 (2) NCT03106779 (2) NCT04106544 (2) NCT04258943 (2) NCT00165984 (2) NCT00977470 (2) NCT02092974 (2) NCT03975231 (2) NCT03586453 (2) NCT01998295 (2) NCT02021305 (2) NCT03135197 (2) NCT00432016 (2) NCT04636437 (2) NCT03004625 (2) NCT03851445 (2) NCT04031898 (2) NCT04201418 (2) NCT01911507 (2) NCT03539224 (2) NCT01978236 (2) NCT00866177 (2) NCT00320879 (2) NCT00044304 (2) NCT01999179 (2) NCT00977730 (2) NCT02491775 (2) NCT00212147 (2) NCT02040064 (2) NCT00489385 (2) NCT01713023 (2) NCT04122729 (2) NCT03994393 (2) NCT02438722 (2) NCT02762448 (2) NCT00071903 (2) NCT00626223 (2) NCT01193829 (2) NCT03239340 (2) NCT02991274 (2) NCT02811354 (2) NCT03416530 (2) NCT02522988 (2) 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NCT03678506 (1) NCT02146365 (1) NCT04310943 (1) NCT02619955 (1) NCT02934139 (1) NCT00400387 (1) NCT00375219 (1) NCT00149305 (1) NCT03520946 (1) NCT02787447 (1) NCT04501614 (1) NCT03166631 (1) NCT04213313 (1) NCT02078531 (1) NCT02349048 (1) NCT02981784 (1) NCT04636593 (1) NCT01647711 (1) NCT03231722 (1) NCT03576937 (1) NCT04412070 (1) NCT00554866 (1) NCT03151161 (1) NCT01817166 (1) NCT02220855 (1) NCT02512627 (1) NCT04591197 (1) NCT03402048 (1) NCT04500704 (1) NCT02323724 (1) NCT01166126 (1) NCT03029858 (1) NCT04317599 (1) NCT00300573 (1) NCT00809211 (1) NCT01393730 (1) NCT02318368 (1) NCT02228369 (1) NCT04500717 (1) NCT01074398 (1) NCT03134131 (1) NCT02455167 (1) NCT01004497 (1) NCT02073279 (1) NCT02117817 (1) NCT00323687 (1) NCT01605981 (1) NCT01371955 (1) NCT04147767 (1) NCT04144257 (1) NCT03490123 (1) NCT04423185 (1) NCT02625337 (1) NCT03567629 (1) NCT03360929 (1) NCT00109278 (1) NCT04108156 (1) NCT02132598 (1) NCT00542451 (1) NCT01587573 (1) NCT00868465 (1) NCT01494402 (1) 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SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03455829

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

Phase 1b/2 Safety, Pharmacokinetic, and Efficacy Study of G1T38 in Combination With Osimertinib in Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)

This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer. The study is an open-label design, consists of 2 parts: safety, pharmacokinetic, and dose-finding portion (Part 1), and randomized portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 144 patients will be enrolled in the study.

NCT03455829 Carcinoma, Non-Small-Cell Lung Lung Cancer Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: G1T38

Description: CDK 4/6 inhibitor
Type: Drug
Group Labels: 2

Part 1: G1T38 + Osimertinib Part 2: G1T38 + Osimertinib

Name: Osimertinib

Description: EGFR TKI; 80 mg
Type: Drug
Group Labels: 3

Part 1: G1T38 + Osimertinib Part 2: G1T38 + Osimertinib Part 2: Osimertinib


Primary Outcomes

Measure: Dose Limiting Toxicity

Time: Cycle 1 Day -14 to Cycle 1 Day 28

Measure: Recommended Phase 2 dose

Time: 9 months

Description: All AEs, including clinical laboratory, vitals signs, physical examinations and ECGs will be analyzed in all patients receiving study drug from the signing of the informed consent until 30 days after the last dose of study medication

Measure: Number of Treatment Related Adverse Event, including Abnormal Laboratory Events

Time: 36 months

Measure: Progression free survival (PFS) using blinded independent central review (BICR)

Time: 36 months

Secondary Outcomes

Measure: Tumor response based on RECIST, Version 1.1

Time: 21 months

Measure: Pharmacokinetics of G1T38 and metabolite G1T30: Maximum Plasma Concentration (Cmax)

Time: Part 1, Cycle 1 Day -14 to Day -2. Part 2, Cycle 1 Day 15 to Cycle 2 Day 1.

Measure: Pharmacokinetics of G1T38 and metabolite G1T30: Area under Curve - plasma concentration (AUC)

Time: Part 1, Cycle 1 Day -14 to Day -2. Part 2, Cycle 1 Day 15 to Cycle 2 Day 1.

Measure: Pharmacokinetics of G1T38 and metabolite G1T30: Plasma: terminal half life (T1/2)

Time: Part 1, Cycle 1 Day -14 to Day -2. Part 2, Cycle 1 Day 15 to Cycle 2 Day 1.

Measure: Pharmacokinetics of G1T38 and metabolite G1T30: Plasma - Volume of distribution

Time: Part 1, Cycle 1 Day -14 to Day -2. Part 2, Cycle 1 Day 15 to Cycle 2 Day 1.

Measure: PFS using investigator assessment

Time: 36 months

Measure: 1-year PFS using investigator assessment and BICR

Time: 33 months

Measure: Overall survival (OS)

Time: 60 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

Inclusion Criteria: - Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity - For Part 2, EGFR T790M mutation-positive tumor status - Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range - For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1 - For Part 2, measurable disease as defined by RECIST, Version 1.1 - ECOG performance status 0 to 1 - Adequate organ function Exclusion Criteria: - Prior treatment with EGFR TKI within 9 days of first study dose - For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC - For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI - For Part 2, prior chemotherapy for advanced NSCLC - Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease - Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose - Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow - Prior hematopoietic stem cell or bone marrow transplantation Inclusion Criteria: - Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity - For Part 2, EGFR T790M mutation-positive tumor status - Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range - For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1 - For Part 2, measurable disease as defined by RECIST, Version 1.1 - ECOG performance status 0 to 1 - Adequate organ function Exclusion Criteria: - Prior treatment with EGFR TKI within 9 days of first study dose - For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC - For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI - For Part 2, prior chemotherapy for advanced NSCLC - Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease - Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose - Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow - Prior hematopoietic stem cell or bone marrow transplantation Carcinoma, Non-Small-Cell Lung Lung Cancer Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- T790M ---

Inclusion Criteria: - Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity - For Part 2, EGFR T790M mutation-positive tumor status - Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range - For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1 - For Part 2, measurable disease as defined by RECIST, Version 1.1 - ECOG performance status 0 to 1 - Adequate organ function Exclusion Criteria: - Prior treatment with EGFR TKI within 9 days of first study dose - For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC - For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI - For Part 2, prior chemotherapy for advanced NSCLC - Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease - Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose - Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow - Prior hematopoietic stem cell or bone marrow transplantation Inclusion Criteria: - Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity - For Part 2, EGFR T790M mutation-positive tumor status - Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range - For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1 - For Part 2, measurable disease as defined by RECIST, Version 1.1 - ECOG performance status 0 to 1 - Adequate organ function Exclusion Criteria: - Prior treatment with EGFR TKI within 9 days of first study dose - For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC - For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI - For Part 2, prior chemotherapy for advanced NSCLC - Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease - Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose - Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow - Prior hematopoietic stem cell or bone marrow transplantation Carcinoma, Non-Small-Cell Lung Lung Cancer Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- T790M --- --- T790M ---

Inclusion Criteria: - Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity - For Part 2, EGFR T790M mutation-positive tumor status - Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range - For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1 - For Part 2, measurable disease as defined by RECIST, Version 1.1 - ECOG performance status 0 to 1 - Adequate organ function Exclusion Criteria: - Prior treatment with EGFR TKI within 9 days of first study dose - For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC - For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI - For Part 2, prior chemotherapy for advanced NSCLC - Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease - Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose - Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow - Prior hematopoietic stem cell or bone marrow transplantation Inclusion Criteria: - Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity - For Part 2, EGFR T790M mutation-positive tumor status - Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range - For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1 - For Part 2, measurable disease as defined by RECIST, Version 1.1 - ECOG performance status 0 to 1 - Adequate organ function Exclusion Criteria: - Prior treatment with EGFR TKI within 9 days of first study dose - For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC - For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI - For Part 2, prior chemotherapy for advanced NSCLC - Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease - Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose - Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow - Prior hematopoietic stem cell or bone marrow transplantation Carcinoma, Non-Small-Cell Lung Lung Cancer Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- T790M --- --- T790M --- --- T790M ---

Inclusion Criteria: - Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity - For Part 2, EGFR T790M mutation-positive tumor status - Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range - For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1 - For Part 2, measurable disease as defined by RECIST, Version 1.1 - ECOG performance status 0 to 1 - Adequate organ function Exclusion Criteria: - Prior treatment with EGFR TKI within 9 days of first study dose - For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC - For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI - For Part 2, prior chemotherapy for advanced NSCLC - Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease - Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose - Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow - Prior hematopoietic stem cell or bone marrow transplantation Inclusion Criteria: - Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity - For Part 2, EGFR T790M mutation-positive tumor status - Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range - For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1 - For Part 2, measurable disease as defined by RECIST, Version 1.1 - ECOG performance status 0 to 1 - Adequate organ function Exclusion Criteria: - Prior treatment with EGFR TKI within 9 days of first study dose - For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC - For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI - For Part 2, prior chemotherapy for advanced NSCLC - Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease - Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose - Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow - Prior hematopoietic stem cell or bone marrow transplantation Carcinoma, Non-Small-Cell Lung Lung Cancer Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- T790M --- --- T790M --- --- T790M --- --- T790M ---



HPO Nodes


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