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Carcinoma, Non-Small-Cell LungPhase 2TRUMPNCT03574402

Phase II Umbrella Study Directed by Next Generation Sequencing

A Phase 2 study testing Avitinib Maleate, Afatinib and Crizotinib in people with Carcinoma, Non-Small-Cell Lung, run by Guangdong Association of Clinical Trials at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This phase II, umbrella trial study directed by next generation sequencing (NGS) works in Chinese patients with advanced stage NSCLC who never received any anti-tumor treatment. The purpose of this study is to evaluate efficacy of targeted therapies or immunotherapy to NSCLC patients whose tumor harbors a genomic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Avitinib Maleate, Afatinib and Crizotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteChina
Study dates
9 Jul 2018to 30 Dec 2024
Phase
Phase 2
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

  • Histologically or cytologically confirmed, unresectable stage IIIB or stage IV NSCLC
  • Patients who have never received any anticancer treatment regimen Note: Patients that have received adjuvant or neoadjuvant chemotherapy and developed metastatic disease after 12 months from the end of that therapy would be eligible for enrollment.
  • Measurable disease according to RECIST v.1.1 (Irradiated lesions are not considered measurable unless they have clearly progressed since radiotherapy)
  • With or without brain or leptomeningeal metastasis (BM/LM). For patients with symptoms of BM/LM, no need for local therapy should be confirmed by investigator and no dramatic decline of performance status in 2 weeks.
  • ECOG performance status ≤ 2
  • Expected survival > 12 weeks
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  • Patients must be suitable and willing to undergo mandatory tumor biopsy according to treating institution's guidelines and requirements for such procedure if there is no archival biopsy available.
  • Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures.
  • Palliative radiotherapy was allowed before enrollment, and radiotherapy-related toxicity grade should no more than 1 (ctcae4.03).
  • No anti-tumor Chinese medicine has been used in the past, or has been used for no more than 3 doses, and stopped for more than 2 weeks before enrollment.
  • Absolute neutrophil count (ANC) ≥ 1.5x10^9/L without the use of growth factor in the past 14 days. Platelets ≥ 90 × 10^9/L without blood transfusion in the past 14 days. Hemoglobin > 9g/dL.
  • Negative pregnancy test (only for women with pregnancy possibility). No possibility of pregnancy defined as at least one year after menopause, or having undergone surgical sterilization or hysterectomy. All patients (male or female) agreed to take contraceptive measures during the treatment and within 8 weeks after the treatment.

Who cannot join

  • Active hepatitis (HBsAg positive and HBV copy number in upper limit of normal)
  • Previous or current active interstitial lung disease (ILD)
  • Patients known to be HIV positive or with other acquired, congenital immunodeficiency diseases, or with a medical history of organ transplantation.
  • Major surgery ≤ 2 weeks prior to study entry.
  • Any other malignancies within the last 5 years before study enrollment, except for un completely resected basal cell carcinoma, in situ bladder cancer, cervical carcinoma in situ.
  • Patients previously treated with the investigational drugs or known to be allergic to ingredients or excipients of the investigational drugs.
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  • Pregnant or lactating women.
  • Patients with swallowing dysfunction, active gastrointestinal disease or other diseases that significantly affect the absorption, distribution, metabolism and excretion of oral drugs. The patients who have had subtotal gastrectomy before. (this standard is applicable to the arms with oral drugs only)
  • Body temperature above 38 ℃ in the past week, or there was active infection with clinical significance. Active tuberculosis;
  • Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [higher than CTCAE Level 3 hypertension after drug treatment]);
  • Patients with bleeding tendency or taking anticoagulants ;
  • There are significant clinical abnormalities in rhythm, conduction or morphology of resting ECG, such as complete left bundle branch block, heart block above degree II, clinically significant ventricular arrhythmia or atrial fibrillation, unstable angina, congestive heart failure, chronic heart failure with NYHA grade ≥ 2.
  • Myocardial infarction, coronary / peripheral artery bypass or cerebrovascular accident occurred within 3 months.
  • QTc of 12 lead ECG was ≥ 450 ms in male and ≥ 470 ms in female;
  • Diagnosed with another malignant disease in the past five years besides NSCLC.
  • More than 30% of the bone marrow had received radiotherapy within 4 weeks before treatment.
  • Any drugs known to extend QT interval were being used within 2 weeks prior to first administration.
  • Strong CYP3A4 inhibitor/inductionor or CYP3A4 substrate were used within 2 weeks, including but not limited to azanavir, clarithromycin, inddenavir, itraconazole, ketoconazole, nefazodone, nefinavir, ritonavir, xaquinavir, talicamycin, acesodamycin, voriconazole, carbamazepine, phenobarbital, phenytoin, rifampin, rifampin, Hypericum perforatum, dihydroergotamine, ergotamine, pimozite, astemizole, cisapride and terfenadine.
  • Strong P-gp inhibitor was used within 2 weeks (including but not limited to verapamil, cyclosporine A and right verapamil).
  • Other potential risks that are not suitable for the study.

Trial locations and contacts

1 site in 1 country.

Yi-Long Wu, Professor contact

862083827812

syylwu@live.cn

Qing Zhou, Dr. contact

+8613544561166

gzzhouqing@126.com

China1 site, 1 recruiting

  • Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology

    Guangzhou, Guangdong, 510080

    Yi-Long Wu, Professor., 862083827812, syylwu@live.cn

    Qing Zhou, Dr., gzzhouqing@126.com

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multi-center, Phase II Umbrella Study to Assess Efficacy of Targeted Therapy or Immunotherapy Directed by Next Generation Sequencing (NGS) in Chinese Patients With Advanced NSCLC (TRUMP)

This phase II, umbrella trial study directed by next generation sequencing (NGS) works in Chinese patients with advanced stage NSCLC who never received any anti-tumor treatment. The purpose of this study is to evaluate efficacy of targeted therapies or immunotherapy to NSCLC patients whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the anti-tumor efficacy of targeted agents or checkpiont inhibitors in advanced stage NSCLC with genomic alteration.

SECONDARY OBJECTIVES:

  1. To evaluate the clinical efficacy of targeted agents or checkpiont inhibitors in advanced stage NSCLC with genomic alteration.

II. To evaluate safty and tolerence of targeted agents or checkpiont inhibitors in advanced stage NSCLC with genomic alteration.

Being tested
Avitinib Maleate, Afatinib, Crizotinib, X-396, Chidamide
Keywords
NSCLC, advanced stage, high throughput sequencing, targeted therapy, immunotherapy
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.

  • Avitinib MaleateDrug

    Also called AC0010

    300mg orally (PO) twice daily (BID) on day 1-28.

  • AfatinibDrug

    Also called Giotrif

    40mg orally once a day, 28 days as one cycle.

  • CrizotinibDrug

    Also called Xalkori

    250mg PO QD on days 1-28. 28 days as one cycle.

  • X-396Drug

    Also called ensartinib

    225mg PO QD on days 1-28. 28 days as one cycle.

  • ChidamideDrug

    Also called Epidaza

    30mg orally twice weekly, 28 days as one cycle.

  • Pyrotinib MaleateDrug

    Also called SHR1258

    400mg PO QD on days 1-28. 28 days as one cycle.

  • AZD3759Drug

    200mg PO BID on days 1-28. 28 days as one cycle.

  • PirotinibDrug

    Also called KBP-5209

    60mg PO QD/40mg PO BID on days 1-28. 28 days as one cycle.

  • NimotuzumabDrug

    400mg, iv gtt. on day 1,8,15. 21 days as one cycle.

  • PemetrexedDrug

    Also called LY231514

    500mg/m^2, iv gtt. Q3W. 21 days as one cycle.

  • CisplatinDrug

    Also called CDDP

    75mg/m^2, iv gtt. Q3W on day1. 21 days as one cycle.

  • SintilimabDrug

    200mg iv gtt. Q3W on day1. 21 days as one cycle.

  • GemcitabineDrug

    Also called LY188011

    1g/m^2 iv gtt. on day1,8. 21 days as one cycle.

  • GemcitabineDrug

    Also called LY188011

    1.25g/m^2 iv gtt. on day1,8. 21 days as one cycle.

  • CarboplatinDrug

    Also called NSC 241240

    AUC5 iv gtt. Q3W on day1. 21 days as one cycle.

Study groups in NCT03574402
Study groupRoleWhat they receive
Arm1: Avitinib MaleateExperimentalPatients with EGFR de novo T790m mutation receive Avitinib 300mg orally (PO) twice daily (BID) on day 1-28.
Receives: Drug: Avitinib Maleate
Arm2: Chidamide plus AfatinibExperimentalPatients with EGFR sensitive mutation with BIM deletion polymorphism receive Afatinib plus Chidamide. Chidamide will be administered 30mg orally twice weekly, 28 days as one cycle. Afatinib will be administered 40mg orally once a day, 28 days as one cycle.
Receives: Drug: Afatinib; Drug: Chidamide
Arm3: crizotinibExperimentalPatients with MET 14 exon mutation receive crizotinib 250mg PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Crizotinib
Arm4: X396ExperimentalPatients with MET amplification receive X396 225mg PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: X-396
Arm5: X396ExperimentalPatients with ROS1 fusion receive X396 225mg PO QD on days 1-28. 28 days as one cycle. Courses repeat every 2 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: X-396
Arm6: X396ExperimentalPatients with Ntrk1/2/3 fusion receive X396 225mg PO QD on days 1-28. 28 days as one cycle. Courses repeat every 2 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: X-396
Arm7: Pyrotinib MaleateExperimentalPatients with HER2 mutation receive Pyrotinib Maleate 400mg PO QD on days 1-28. 28 days as one cycle. Courses repeat every 2 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Pyrotinib Maleate
Arm8: AZD3759ExperimentalEGFR sensitive mutation with brain/meningeal metastasis receive AZD3759 200mg PO BID on days 1-28. 28 days as one cycle. Courses repeat every 2 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: AZD3759
Arm9: PirotinibExperimentalPatients with EGFR20ins mutation positive receive Pirotinib. This arm was divided into three groups: Group 1, 60mg PO QD on days 1-28. 28 days as one cycle. Group 2, 40mg PO BID on days 1-28. 28 days as one cycle. Group 3, Dosage was determined according to the number of PR patients in Group 2.
Receives: Drug: Pirotinib
Arm10: Nimotuzumab plus gemcitabine and carboplatinExperimentalLung squamous cell carcinoma with EGFR amplification. Nimotuzumab 400mg, iv gtt. on day 1,8,15. Gemcitabine 1250mg/m^2, iv gtt. on day 1,8. Carboplatin AUC5, iv gtt. Q3W on day 1. 21 days as one cycle. Courses repeat every 2 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Nimotuzumab; Drug: Gemcitabine; Drug: Carboplatin
Arm11: Nimotuzumab plus pemetrexed and cisplatinExperimentalLung adenocarcinoma with EGFR amplification. Nimotuzumab 400mg, iv gtt. on day 1,8,15. pemetrexed 500mg/m^2, iv gtt. on day 1. Cisplatin 75mg/m^2, iv gtt. Q3W on day 1. 21 days as one cycle. Courses repeat every 2 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Nimotuzumab; Drug: Pemetrexed; Drug: Cisplatin
Arm12: PirotinibExperimentalPatients with rare EGFR mutation receive Pirotinib. This arm was divided into two groups: Group 1, 40mg PO BID on days 1-28. 28 days as one cycle. Group 2, Dosage was determined according to the number of PR patients in Group 1.
Receives: Drug: Pirotinib
Arm13: AvitinibExperimentalPatients with EGFR sensitive mutation receive Avitinib 300mg PO BID on days 1-28. 28 days as one cycle. Courses repeat every 2 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Avitinib Maleate
Arm14: SintilimabExperimentalPatients with PD-L1(TPS)≥50% without EGFR mutation or ALK rearrangement. Sintilimab 200mg iv gtt. Q3W on day1. 21 days as one cycle. Courses repeat every 2 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Sintilimab
Arm15: SintilimabExperimentalPatients with TMB≥10 mut/Mb，1%≦PD-L1<50% without EGFR mutation or ALK rearrangement. Sintilimab 200mg iv gtt. Q3W on day1. 21 days as one cycle. Courses repeat every 2 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Sintilimab
Arm16: SintilimabExperimentalPatients with KRAS and TP53 mutation, 1%≦PD-L1<50%, TMB<10 mut/Mb without EGFR mutation or ALK rearrangement. Sintilimab 200mg iv gtt. Q3W on day1. 21 days as one cycle. Courses repeat every 2 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Sintilimab
Arm17: Sintilimab plus pemetrexed and cisplatinExperimentalPatients with PD-L1<1%, TMB<10 mut/mb without EGFR mutation, ALK rearrangement, KRAS or TP53 mutation. Sintilimab 200mg iv gtt. Q3W on day1. Pemetrexedb 500mg/m^2 iv gtt. Q3W on day1. Cisplatin 75mg/m^2 iv gtt. Q3W on day1. 21 days as one cycle. Courses repeat every 2 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Sintilimab
Arm18: Sintilimab plus Gemcitabine and carboplatinExperimentalPatients with PD-L1<1%, TMB<10 mut/mb without EGFR mutation, ALK rearrangement, KRAS or TP53 mutation. Sintilimab 200mg iv gtt. Q3W on day1. Gemcitabine 1g/m^2 iv gtt. on day1,8. Carboplatin AUC5 iv gtt. Q3W on day1. 21 days as one cycle. Courses repeat every 2 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Sintilimab; Drug: Gemcitabine; Drug: Carboplatin

What is being measured

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

  1. Response rate (RR)

    RECIST version 1.1

    Measured: 24 months

Secondary outcomes (7)

  1. Progression-free survival (PFS)

    RECIST version 1.1

    Measured: 24 months

  2. Overall survival (OS)

    Overall Survival is defined as the time from first dose to death due to any cause. Through the follow-up within 30 days after study completion or termination of the last subject, death and date of death will be checked for subject alive during treatment period

    Measured: 48 months

  3. Disease control rate（DCR）

    RECIST version 1.1

    Measured: 24 months

  4. Duration of response (DOR)

    RECIST version 1.1

    Measured: 24 months

  5. Toxicity (number of patients with treatment-related AE as assessed by CTCAE v4.03)

    number of patients with treatment-related AE as assessed by CTCAE v4.03

    Measured: 24 months

  6. Health-Related Quality of Life (HRQOL)

    EORTC-LC13

    Measured: 24 months

  7. To explore the mechanism of drug resistance in the treatment of specific gene mutation

    Measured: 24 months

Timeline

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

  1. First posted2 Jul 2018
  2. Study start9 Jul 2018
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2024 (estimated)

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03574402
Sponsor's protocol ID
CTONG1702
Acronym
TRUMP
Status last verified
Dec 2022
First submitted
20 Jun 2018
Last updated
6 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu SM, Tu HY, Wei XW, Yan HH, Dong XR, Cui JW, Zhou Z, Xu CR, Zheng MY, Li YS, Wang Z, Bai XY, Li AN, Sun YL, Huang J, Lin JX, Ke EE, Xu BF, Lu C, Du Y, Chen Y, Ma R, Wang BH, Cang SD, Wang BC, Chen HJ, Yang JJ, Li Y, Zhou Q, Wu YL. First-line pyrotinib in advanced HER2-mutant non-small-cell lung cancer: a patient-centric phase 2 trial. Nat Med. 2023 Aug;29(8):2079-2086. doi: 10.1038/s41591-023-02461-x. Epub 2023 Jul 24.

    PubMed 37488286

  • Liu SM, Yan HH, Wei XW, Lu C, Dong XR, Du Y, Cui JW, Chen Y, Ma R, Wang BH, Zhou Z, Cang SD, Yang JJ, Tu HY, Zhang XC, Zhong WZ, Zhou Q, Wu YL. Biomarker-Driven Studies With Multi-targets and Multi-drugs by Next-Generation Sequencing for Patients With Non-Small-Cell Lung Cancer: An Open-Label, Multi-center, Phase II Adaptive Umbrella Trial and a Real-World Observational Study (CTONG1702&CTONG1705). Clin Lung Cancer. 2022 Nov;23(7):e395-e399. doi: 10.1016/j.cllc.2022.05.009. Epub 2022 May 11.

    PubMed 35659479

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avitinib Maleate, Afatinib and Crizotinib in people with Carcinoma, Non-Small-Cell Lung, run by Guangdong Association of Clinical Trials at 1 site in China.

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 12 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Yi-Long Wu, Professor (862083827812, syylwu@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (RR) (time frame: 24 months). 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 NCT03574402, which also lists 2 linked publications.

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 6 Dec 2022.

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