Lung Cancer Clinical Trial

Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer

Summary

This is a phase III randomized open label study designed to compare JDQ443 as monotherapy to docetaxel in participants with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum-based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination.

View Full Description

Full Description

The study has been designed as a Phase III trial and consists of 2 parts:

Randomized part will evaluate the efficacy and safety of JDQ443 as monotherapy in comparison with docetaxel. Participants randomized to docetaxel arm will have the opportunity to cross-over to JDQ443 at disease progression per RECIST 1.1 confirmed by BIRC.
Extension part will be open after final progression-free survival (PFS) analysis (if the primary endpoint has met statistical significance) to allow participants randomized to docetaxel treatment to crossover to receive JDQ443 treatment regardless of progression on docetaxel.

The study population will include adult participants with locally advanced or metastatic (stage IIIB/IIIC or IV) KRAS G12C mutant non-small cell lung cancer (by tissue or plasma as determined by a Novartis-designated central laboratory or accepted local tests) who have received prior platinum-based chemotherapy and prior immune checkpoint inhibitor therapy administered either in sequence or as combination therapy.

Approximately 360 participants will be randomized to JDQ443 or docetaxel in a 1:1 ratio stratified by prior line of therapy and ECOG performance status.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novartis designated central laboratory or by accepted local tests.
Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease
Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit.

Exclusion Criteria:

Participants who have previously received docetaxel (except if received in neoadjuvant or adjuvant setting with no progression within 12 months after the of end of treatment), or any other KRAS G12C inhibitor.
Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other druggable alterations will be excluded if required by local guidelines.
Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Participant has an history of interstitial lung disease or pneumonitis grade > 1.

Other inclusion/exclusion criteria may apply

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

360

Study ID:

NCT05132075

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 144 Locations for this study

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Mid Florida Hematology And Onc Ctr
Orange Florida, 32763, United States More Info
Amanda Wise
Contact
386-774-1223
[email protected]
Santosh Nair
Principal Investigator
Hope And Healing Care Research
Hinsdale Illinois, 60521, United States More Info
Praneetha Achanta
Contact
[email protected]
Srilata Gundala
Principal Investigator
Exeter Hospital
Exeter New Hampshire, 03833, United States More Info
Julie Bushey
Contact
[email protected]
Panos Fidias
Principal Investigator
Clinical Research Alliance Research
Lake Success New York, 11042, United States More Info
Krishna Pandit
Contact
+1 516 488 2918#183
[email protected]
James D Olimpio
Principal Investigator
Valley Medical Center Research Valley Professional Center Bld
Renton Washington, 98055, United States More Info
Melissa Bennett
Contact
[email protected]
Navanshu Arora
Principal Investigator
Novartis Investigative Site
Caba Buenos Aires, C1414, Argentina
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La Plata Buenos Aires, B1900, Argentina
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Pilar Buenos Aires, B1629, Argentina
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Buenos Aires , C1431, Argentina
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Cordoba , X5000, Argentina
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Auchenflower Queensland, 4066, Australia
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Hyde Park Queensland, 4812, Australia
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South Brisbane Queensland, 4101, Australia
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Southport Queensland, 4215, Australia
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Rio de Janeiro RJ, 22640, Brazil
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Ijuí RS, 98700, Brazil
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Sao Paulo SP, 01308, Brazil
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Rio Grande Do Sul , 90035, Brazil
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Sao Paulo , 01509, Brazil
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Plovdiv , 4004, Bulgaria
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Russe , 7002, Bulgaria
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Sofia , 1303, Bulgaria
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Levis Quebec, G6V 3, Canada
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Montreal Quebec, H4A 3, Canada
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Sherbrooke Quebec, J1H 5, Canada
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Santiago Region Metropolitana, 75609, Chile
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Hefei Anhui, 23000, China
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Fuzhou Fujian, 35001, China
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Guangzhou Guangdong, 51000, China
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Guangzhou Guangdong, 51008, China
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Shenzhen Guangdong, 51800, China
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Harbin Heilongjiang, 15008, China
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Wuhan Hubei, 43002, China
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Wuhan Hubei, 43006, China
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Changsha Hunan, 41001, China
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Nanjing Jiangsu, 21000, China
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Jinan Shandong, 25011, China
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Chengdu Sichuan, 61004, China
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Hangzhou Zhe Jiang, 31000, China
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Hangzhou Zhejiang, 31002, China
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Beijing , 10003, China
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Beijing , 10073, China
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Chongqing , 40004, China
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Shanghai , 20002, China
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Zhengzhou , 45000, China
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Medellin Antioquia, 05000, Colombia
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Valledupar Cesar, 56023, Colombia
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Monteria , 23000, Colombia
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Zagreb , 10000, Croatia
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Ostrava Vitkovice , 703 8, Czechia
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Odense C , DK 50, Denmark
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Tartu , 50406, Estonia
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Turku , FI-20, Finland
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Vaasa , 65130, Finland
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Athens GR, 115 2, Greece
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Athens , 11526, Greece
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Heraklion Crete , 711 1, Greece
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Thessaloniki , 54622, Greece
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Hong Kong , 99907, Hong Kong
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Kowloon , , Hong Kong
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Shatin New Territories , , Hong Kong
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Torokbalint Pest, 2045, Hungary
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Budapest , 1121, Hungary
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Reykjavik , IS-10, Iceland
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Hyderabad Andhra Pradesh, 500 0, India
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Visakhapatnam Andhrapradesh, 53001, India
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Bangalore Karnataka, 56007, India
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Nashik Maharashtra, 422 0, India
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Jaipur Rajasthan, 30201, India
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Kolkata West Bengal, 70016, India
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Delhi , 110 0, India
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Mumbai , 400 0, India
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Lucca LU, 55100, Italy
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Aviano PN, 33081, Italy
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Roma RM, 00128, Italy
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Amman , 11941, Jordan
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Amman , 1857, Jordan
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Irbid , 22110, Jordan
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Daegu Dalseo Gu, 42602, Korea, Republic of
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Seongnam Si Gyeonggi Do, 13620, Korea, Republic of
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Seoul Korea, 08308, Korea, Republic of
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Seoul Seocho Gu, 06591, Korea, Republic of
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Busan , 49241, Korea, Republic of
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Jinju , 660-7, Korea, Republic of
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Seoul , 05030, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Ashrafieh , 16683, Lebanon
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Beirut , 1107 , Lebanon
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Dora , 90375, Lebanon
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Saida , 652, Lebanon
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Kuching Sarawak, 93586, Malaysia
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Petaling Jaya Selangor Darul Ehsan, 46150, Malaysia
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Petaling Jaya Selangor, 46050, Malaysia
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Kuala Lumpur , 59100, Malaysia
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Cuautitlan Izcalli Estado De Mexico, 54769, Mexico
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Guadalajara Jalisco, 44280, Mexico
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Mexico City , 06760, Mexico
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Veracruz , 91900, Mexico
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Drammen , 3004, Norway
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Oslo , NO 04, Norway
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Trondheim , 7006, Norway
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Rzeszow , 35-05, Poland
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Warszawa , 02 78, Poland
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Lisboa , 1998-, Portugal
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Matosinhos , 4454 , Portugal
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Porto , 4100-, Portugal
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Alba Iulia Alba, 51007, Romania
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Floresti Cluj, 40728, Romania
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Craiova Dolj, 20034, Romania
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Bucharest , 02232, Romania
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Cluj Napoca , 40005, Romania
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Cluj-Napoca , 40012, Romania
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Constanta , 90590, Romania
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Iasi , 70048, Romania
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Suceava , 72752, Romania
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Timisoara , 30042, Romania
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Belgrade , 11000, Serbia
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Golnik , 4204, Slovenia
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Ljubljana , 1000, Slovenia
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Cordoba Andalucia, 14004, Spain
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Oviedo Asturias, 33011, Spain
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Badalona Catalunya, 08916, Spain
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Alicante Comunidad Valenciana, 03010, Spain
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La Coruna Galicia, 15006, Spain
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Pamplona Navarra, 31008, Spain
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Madrid , 28009, Spain
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Tainan , 70403, Taiwan
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Taipei , 10361, Taiwan
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Taoyuan , 33305, Taiwan
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Khon Kaen THA, 40002, Thailand
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Bangkok , 10110, Thailand
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Bangkok , 10330, Thailand
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Bangkok , 10700, Thailand
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Ankara Yenimahalle, 06200, Turkey
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Adana , 01140, Turkey
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Ankara , 06100, Turkey
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Ankara , 06560, Turkey
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Ankara , 06680, Turkey
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Antalya , 07059, Turkey
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Cankaya Ankara , 06560, Turkey
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Fatih / Istanbul , 34093, Turkey
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Fatih , 34093, Turkey
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Istanbul , 34662, Turkey
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Istanbul , 34890, Turkey
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Sakarya , 54290, Turkey
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Stoke on Trent Staffordshire, ST46Q, United Kingdom
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Staffordshire , WS11 , United Kingdom
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Hanoi , 30000, Vietnam
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Ho Chi Minh , 70000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

360

Study ID:

NCT05132075

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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