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Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)Phase 3NCT04129502

TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

A Phase 3 study testing TAK-788, Pemetrexed and Cisplatin in people with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC), run by Takeda at 134 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TAK-788, Pemetrexed and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
134 sitesin 24 countries
Study dates
10 Jan 2020to 22 Sep 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female adult patients (aged 18 years or older)
  • Histologically or cytologically confirmed nonsquamous cell locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC
  • Documented epidermal growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (US sites) or an accredited (outside of the US) local laboratory The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or human epidermal growth factor receptor 2 (HER2) mutations except EGFR mutations for which there are approved anti-EGFR tyrosine kinase inhibitors [TKIs] (ie, exon 19 del, L858R, T790M, L861Q, G719X, or S768I, where X is any other amino acid)
  • Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR exon 20 insertion mutation
  • At least 1 measurable lesion per RECIST Version 1.1
  • Life expectancy ≥3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Adequate organ and hematologic function as defined by blood transfusions with a recommended >/ 14 day washout period.

Who cannot join

  • Received prior systemic treatment for locally advanced or metastatic disease, including local administration, such as intra-pleural injection of anticancer medication with the exception noted below:
  • Neoadjuvant or adjuvant chemotherapy/immune therapy for Stage I to III or combined modality chemotherapy/radiation for locally advanced disease is allowed if completed >6 months before the development of metastatic disease.
  • Received radiotherapy ≤14 days before randomization or has not recovered from radiotherapy-related toxicities
  • Received a moderate or strong cytochrome P450 (CYP)3A inhibitor or moderate or strong CYP3A inducer within 10 days before first dose of TAK-788
  • Have been diagnosed with another primary malignancy other than NSCLC
  • Have current spinal cord compression or leptomeningeal disease
Show all 9Show fewer
  • Have uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure
  • Received a live vaccine within 4 weeks before randomization per Summary of product characteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin
  • Taking medication(s) known to be associated with the development of torsades de pointes.

Trial locations and contacts

134 sites in 24 countries.

134 sites in 24 countries

China12 sites

  • Beijing Cancer Hospital - PPDS

    Beijing, Beijing Municipality, 100142

  • Beijing Cancer Hospital - PPDS

    Beijing, 100142

  • Beijing Chest Hospital, Capital Medical Univerity

    Beijing, 101149

  • Icahn School of Medicine at Mount Sinai

    Beijing

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • Sichuan Cancer Hospital & Institute

    Chengdu, 610041

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, 310003

  • Harbin Medical University Tumor Hospital

    Harbin, 150081

  • Shanghai East Hospital

    Shanghai, 200123

  • Hubei Cancer Hospital

    Wuhan, 430079

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

Japan12 sites

  • Osaka International Cancer Institute

    Chuo Ku, Osaka, 540-0008

  • National Cancer Center Hospital East

    Kashiwa-Shi, Chiba, 277-0882

  • Saitama Cancer Center

    Komoro, Saitama, 362-0806

  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research

    Koto-Ku, Tokyo, 135-0063

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto, 861-4101

  • Kurume University Hospital

    Kurume-Shi, Hukuoka, 830-0011

  • Ehime University Hospital

    Matsuyama, Ehime, 791-0280

  • Miyagi Cancer Center

    Natori-shi, Miyagi, 981-1239

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-0914

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Fujita Health University Hospital

    Toyoake-Shi, Aiti, 470-1101

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-0815

Other trials in Japan

United States11 sites

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Beth Israel Deaconess Medical Center - 330 Brookline Ave

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Massachusetts General Hospital

    Boston, Massachusetts, 02115

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • City of Hope National Medical Center

    Long Beach, California, 90813

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • University of California Irvine

    Orange, California, 92868

  • AdventHealth

    Orlando, Florida, 32804

  • Stanford University

    Palo Alto, California, 94304

Other trials in United States

France11 sites

  • Centre Francois Baclesse

    Caen, Calvados, 14076

  • CHU de Grenoble

    Grenoble, 38043

  • Hopital Calmette

    Lille, Nord, 59037

  • Centre Leon Berard

    Lyon, Rhone, 69373

  • Hopital Nord AP-HM

    Marseille, 13915

  • CRLC Val d'Aurelle - Paul Lamarque

    Montpellier, 34298

  • CHU de Nantes - Hoptal Nord Laennec

    Nantes, Loire-Atlantique, 44000

  • Hopital Tenon

    Paris, 75020

  • Nouvel Hopital Civil

    Strasbourg, 67091

  • Hopital Larrey

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, Val-de-Marne, 94805

Other trials in France

Spain10 sites

  • Hospital Universitario A Coruna

    A Coruña, 15006

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14004

  • ICO lHospitalet Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Italy9 sites

  • Centro Di Riferimento Oncologico

    Aviano, Pordenone, 33081

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS

    Meldola, Forli-Cesena, 47014

  • Istituto Nazionale Dei Tumori

    Milan, Lombardy, 20133

  • Instituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • AORN Dei Colli- Ospedale Monaldi Napoli

    Naples, Campania, 80131

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Piedmont, 10043

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56124

  • Ospedale Santa Maria Delle Croci

    Ravenna, 48121

Other trials in Italy

South Korea9 sites

  • Pusan National University Hospital

    Busan, 602-739

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • National Cancer Center

    Goyang, 410769

  • Chonnam National University Hwasun Hospital

    Jeongnam, 519-763,

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center - PPDS

    Seoul, 05505

  • Samsung Medical Center PPDS

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 120-752

Other trials in South Korea

Taiwan9 sites

  • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    Dalin, 622

  • National Taiwan University Hospital - YunLin Branch

    Douliu, 640

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • E-DA hospital

    Kaohsiung City, 82445

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chi Mei Medical Center, Liouying

    Tainan, 736

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

Germany6 sites

  • Helios Klinikum Emil Von Behring

    Berlin, 14165

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60596

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, Baden-Wurttemberg, 69126

  • LMU Klinikum der Universitat Munchen

    München, Bavaria, 80336

  • Pius Hospital Oldenburg

    Oldenburg, Lower Saxony, 26121

  • University Clinic Regensburg

    Regensburg, Bavaria, 93053

Other trials in Germany

Hong Kong6 sites

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

  • Queen Elizabeth Hospital (QEH)

    Hong Kong

  • Queen Mary Hospital - PPDS

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

  • Princess Margaret Hospital

    Kowloon City, Kowloon City

  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

Turkey (Türkiye)6 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Ege University Medical Faculty

    Bornova, İzmir, 35100

  • Trakya University Medical Faculty

    Edirne, 22030

  • T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Kadıköy, Istanbul, 34772

  • SAKARYA University Medical Faculty

    Karaman, Sakarya, 54290

  • Baskent University Medical Faculty Adana Practice and Research Center

    Yüreğir, Adana, 01120

Other trials in Turkey (Türkiye)

Portugal5 sites

  • Centro Hospitalar de Lisboa Norte E.P.E Hospital Pulido Valente

    Lisbon, 1769-001

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

    Porto, 4200-072

  • Centro Hospitalar de Sao Joao, E.P.E.

    Porto, 4200

  • Centro Hospitalar do Porto Hospital de Santo Antonio

    Santa Maria da Feira, Aveiro District, 4520-211

  • Hospital Cuf Porto

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

United Kingdom5 sites

  • Clatterbridge Centre For Oncology

    Bebington, Wirral, CH63 4JY

  • Leicester General Hospital

    Leicester, LE1 5WW

  • University College London Hospitals (UCLH)

    London, London, City of, NW1 2PG

  • The Christie NHS Foundation Trust - PPDS

    Manchester, M20 4GJ

  • Royal Marsden Hospital - Surrey

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Canada4 sites

  • William Osler Health System

    Brampton, Ontario, L6R 3J7

  • Hopital Du Sacre Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G2M9

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z-4E6

Other trials in Canada

Australia3 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • GenesisCare North Shore

    St Leonards, New South Wales, 2065

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Belgium3 sites

  • AZ Sint-Lucas

    Aalst, Oost-Vlaanderen, 9300

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital, 1200

  • Grand Hopital de Charleroi asbl

    Charleroi, Hainaut, 6000

Other trials in Belgium

Ukraine3 sites

  • Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS

    Dnipropetrovsk, Dnipropetrovsk Oblast, 49102

  • Communal Non-profit Enterprise Regional Center of Oncology

    Kharkiv, Kharkiv Oblast, 61070

  • Private Enterprise Private Manufacturing Company Acinus

    Kropyvnytskyi, 25006

Other trials in Ukraine

Greece2 sites

  • Sotiria Chest Hospital of Athens

    Athens, Attica, 11527

  • Bioclinic Thessaloniki (Galinos clinic)

    Thessaloniki, 546 29

Other trials in Greece

Israel2 sites

  • Soroka University Medical Centre

    Beersheba, 84101

  • Sheba Medical Center - PPDS

    Ramat Gan, 52621

Other trials in Israel

Russia2 sites

  • GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

    Saint Petersburg, Leningradskaya Oblast', 197758

  • LLC "EuroCityClinic"

    Saint Petersburg, Sankt-Peterburg, 197022

Other trials in Russia

Austria1 site

  • Klinik Floridsdorf

    Vienna, 1210

Other trials in Austria

Netherlands1 site

  • VU Medisch Centrum

    Amsterdam, North Holland, 1081 HV

Other trials in Netherlands

Singapore1 site

  • National Cancer Centre

    Singapore, 169608

Other trials in Singapore

Sweden1 site

  • Karolinska Universitetssjukhuset Solna

    Stockholm, Södermanland County

Other trials in Sweden

About this study

Official title: A Randomized Phase 3 Multicenter Open-Label Study to Compare the Efficacy of TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

The purpose of this study is to compare effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group.

Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.

Read the detailed description

The drug being tested in this study is called TAK-788. TAK-788 is being tested to evaluate the efficacy as a first line treatment compare with platinum-based chemotherapy in the participants with locally advanced or NSCLC whose tumors harbor EGFR exon 20 insertion mutations.

The study will enroll approximately 318 patients. Participants will be randomly assigned to one of the two treatment groups-

  • TAK-788 Group (Arm A)
  • Platinum-based Chemotherapy Group (Arm B)

The participants will be administered with TAK-788 orally in arm A and pemetrexed/cisplatin or pemetrexed/carboplatin intravenously (IV) in arm B until the participants experience progressive disease (PD) as assessed by blinded independent review committee (IRC), intolerable toxicity or another discontinuation criteria. Participants in the chemotherapy group may cross over to treatment with TAK-788 after IRC-assessed PD is documented. Randomized treatment with TAK-788 or platinum-based chemotherapy may be continued after PD, at the discretion of the investigator and with the sponsor's approval, if there is still evidence of clinical benefit.

This multi-center trial will be conducted in United States (US), Europe, and Asia. The overall time to participate in this study is until 3 years after the last participant is randomized. Participants will make multiple visits to the clinic and will be followed for survival, subsequent anticancer therapy, subsequent disease assessment outcome until disease progression on a subsequent anticancer therapy, and participant-reported health status (EuroQoL-5 Dimensions-5 Levels [EQ-5D-5L]) for 3 years after the last participant is randomized in the study and 30 days after the last dose of study drug for safety follow-up.

Being tested
TAK-788, Pemetrexed, Cisplatin, Carboplatin
Keywords
Drug Therapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-788Drug

    Also called AP32788, Mobocertinib

    TAK-788 capsule

  • PemetrexedDrug

    Also called Alimta

    Pemetrexed IV infusion

  • CisplatinDrug

    Cisplatin IV infusion

  • CarboplatinDrug

    Carboplatin IV infusion

Study groups in NCT04129502
Study groupRoleWhat they receive
TAK-788 Group (Arm A)ExperimentalTAK-788 160 milligram (mg) with or without food, capsules, orally, once daily until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria.
Receives: Drug: TAK-788
Platinum-based Chemotherapy Group (Arm B)Active comparatorPemetrexed 500 milligram per meter square (mg/m^2) plus cisplatin 75 mg/m^2, infusion, IV, once on Day 1 of 21-day cycle pemetrexed 500 mg/m^2 plus carboplatin, infusion, IV, once at a dose calculated to produce area under curve (AUC) of 5 milligram*minute per milliliter (mg*min/mL) on Day 1 of 21-day cycle until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria. Pemetrexed/cisplatin or pemetrexed/carboplatin will be repeated every 3 weeks for 4 cycles, followed by maintenance treatment with pemetrexed 500 mg/m^2, on Day 1 of a 21-day cycle thereafter.
Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST Version 1.1 are met or death, whichever occurs first.

    Measured: Up to approximately 40 months after the first participant is randomized

Secondary outcomes (9)

  1. Confirmed Objective Response Rate (ORR) as Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1

    Confirmed ORR is defined as the percentage of participants who are confirmed to have achieved complete response (CR) or partial response (PR). Confirmed responses are responses that persist on repeat imaging ≥4 weeks after initial response.

    Measured: Up to approximately 40 months after the first participant is randomized

  2. Overall Survival (OS)

    OS is defined as the interval from the date of randomization until death.

    Measured: Up to approximately 40 months after the first participant is randomized

  3. Progression Free Survival (PFS) as Assessed by the Investigator

    PFS is defined as the time interval from the date of randomization until the first date at which the criteria for PD according to RECIST Version 1.1 are met or death, whichever occurs first.

    Measured: Up to approximately 40 months after the first participant is randomized

  4. Confirmed Objective Response Rate (ORR) as Assessed by the Investigator

    Confirmed ORR is defined as the percentage of participants who are confirmed to have achieved CR or PR. Confirmed responses are responses that persist on repeat imaging ≥4 weeks after initial response.

    Measured: Up to approximately 40 months after the first participant is randomized

  5. Duration of Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator

    Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that PD or death (whichever occurs first) is objectively documented.

    Measured: Up to approximately 40 months after the first participant is randomized

  6. Time to Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator

    Time to response is defined as the time interval from the date of randomization until the initial observation of CR or PR.

    Measured: Up to approximately 40 months after the first participant is randomized

  7. Disease Control Rate (DCR) as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator

    DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks) after the initiation of study drug.

    Measured: Up to approximately 40 months after the first participant is randomized

  8. Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

    EORTC QLQ-C30 is a cancer-specific questionnaire which comprises of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores will be converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QoL scale, higher scores represent better HRQoL, whereas for the symptom scales lower scores represent better HRQoL (i.e., a low level of symptomatology/problems).

    Measured: Up to approximately 40 months after the first participant is randomized

  9. Participant-reported Symptoms as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, Lung Cancer Module (QLQ-LC13)

    EORTC QLQ-LC13 is a cancer-specific questionnaire which comprises of 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Raw scores will be converted into scale scores ranging from 0 to 100. Higher scores represent a high level of symptomatology/problems.

    Measured: Up to approximately 40 months after the first participant is randomized

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2019
  2. Study start10 Jan 2020
  3. Primary completion22 Sep 2026
  4. Study completion22 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04129502
Sponsor's protocol ID
TAK-788-3001
Other IDs
NL20191212, 2019-001845-42, U1111-1232-6059, jRCT2071210098, 2019
Status last verified
Oct 2026
First submitted
7 Oct 2019
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • Janne PA, Wang BC, Cho BC, Zhao J, Li J, Hochmair M, Peters S, Besse B, Pavlakis N, Neal JW, Kato T, Wu YL, Nguyen D, Lin J, Lin J, Vranceanu F, Szumski A, Lin HM, Fram RJ, Mok TSK. First-Line Mobocertinib Versus Platinum-Based Chemotherapy in Patients With EGFR Exon 20 Insertion-Positive Metastatic Non-Small Cell Lung Cancer in the Phase III EXCLAIM-2 Trial. J Clin Oncol. 2025 May;43(13):1553-1563. doi: 10.1200/JCO-24-01269. Epub 2025 Jan 29.

    PubMed 39879577

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-788, Pemetrexed and Cisplatin in people with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC), run by Takeda at 134 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in China, Japan, United States, France, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: Up to approximately 40 months after the first participant is randomized). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04129502, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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