AzTrials
AzTrials

Non-small-cell Lung CancerPhase 2NCT04382300

Pyrotinib Plus Thalidomide in Advanced NSCLC Patients Harboring HER2 Exon 20 Insertions

A Phase 2 study testing pyrotinib combined with thalidomide in people with Non-small-cell Lung Cancer, run by Shanghai Chest Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in approximately 2% of non-small-cell lung cancers. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non-small-cell Lung Cancer
What is being tested?
pyrotinib combined with thalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
30 Jun 2020to Apr 2023
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-80 years.
  • ECOG performance status 0-1.
  • Life expectancy ≥12 weeks.
  • At least one measurable lesion according to RECIST 1.1.
  • Histologically or cytologically confirmed advanced (IIIB or IV) non-small-cell lung cancer according to the 7th edition of TNM classification and staging system for lung cancer published by IASLC.
  • HER2 exon 20 insertions confirmed by next generation sequencing or polymerase chain reaction (if blood samples are used, the mutation abundance should be ≥10%).
Show all 13Show fewer
  • Disease progression during or after platinum-based chemotherapy, or refusing chemotherapy (patients are allowed to have prior therapy with PD-1/PD-L1 inhibitors and/or antiangiogenic agents).
  • No more than two prior chemotherapy regimens (a. replacing platinum drug due to toxicity is considered as a new regimen; b. adjuvant chemotherapy is not considered as a prior regimen if disease recurrence occurred at more than 6 months after the last dose).
  • No radiotherapy within 3 months, or prior radiotherapy with radiation area <25% of bone marrow area at least 4 weeks before enrollment.
  • Required laboratory values including following parameters:
  • ANC: ≥ 1.5 × 10^9/L, Platelet count: ≥ 90 × 10^9/L, Hemoglobin: ≥ 90 g/L, INR: ≤1.5, APTT: ≤1.5 × ULN, Total bilirubin: ≤ 1.5 × ULN, ALT and AST: ≤ 2 × ULN for liver metastases, BUN and creatine: ≤ 1.5 × ULN, creatine clearance rate: ≥ 50 mL/min, LVEF: ≥ 50%, QTcF: < 470 ms for female, < 450 ms for male.
  • Willingness to use highly effective contraception from the start of the study to 90 days after the last dose of study drug.
  • Written informed consent.

Who cannot join

  • Prior HER2-targeting therapies.
  • Other gene alterations with available targeted drugs, such as EGFR mutations, T790M resistance mutations, ALK fusions, ROS1 fusions, RET rearrangements, BRAF V600E mutations, NTRK fusions, and MET exon 14 skipping.
  • Factors influencing the oral administration of drugs, such as inability to swallow, chronic diarrhea, intestinal obstruction, or other gastrointestinal diseases or abnormalities.
  • With third space effusion that can not be controlled by drainage or other methods.
  • Radiotherapy, chemotherapy, surgery, or other targeted therapy for non-small-cell lung adenocarcinoma within 4 weeks.
  • Active brain metastases, meningeal metastases, spinal compression, or CT or MRI revealing brain or leptomeningeal diseases at screening (patients with symptomatically stable brain metastases can be enrolled if no cerebral hemorrhage is found by brain MRI, CT or venography).
Show all 20Show fewer
  • Uncontrolled hypokalemia or hypomagnesemia.
  • Allergy history to the components of study drug.
  • History of immunodeficiency disease (including positive test of human immunodeficiency virus, active hepatitis B/C, or other acquired or congenital immunodeficiency disease) or organ transplantation.
  • History of cardiac diseases, including angina, arrhythmia requiring drug therapy or of clinical significance, myocardial infarction, heart failure, and other cardiac diseases unsuitable for this trial as judged by the investigator.
  • Patients with thrombotic disease or previous history of thrombosis.
  • Other malignancies within 5 years, except for cured cervical cancer in situ, skin basal cell cancer, and skin squamous cell cancer.
  • History of neurological or mental disorders, such as epilepsy and dementia.
  • Respiratory syndrome (dyspnea ≥grade 2 using NCI CTCAE 5.0).
  • Coagulation disorders (INR >1.5, prothrombin time >ULN + 4 s, or APTT >1.5×ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy.
  • Renal dysfunction (urine protein ≥++, or 24-hour proteinuria ≥1.0 g).
  • Participating in other clinical trials within 4 weeks.
  • Pregnant or lactating woman.
  • Concomitant diseases seriously affecting the patient safety or the completion of study as judged by the investigator, such as uncontrolled severe hypertension, severe diabetes mellitus, and active infection.
  • Any other condition unsuitable for the study as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

Shun Lu contact

86-21-22200000

shunlu@sjtu.edu.cn

China1 site, 1 recruiting

  • Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University

    Shanghai, 200030

    Shun Lu, 86-21-22200000, shunlu@sjtu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Pyrotinib Combined With Thalidomide in Advanced Non-Small-Cell Lung Cancer With HER2 Exon 20 Insertions: A Prospective, Single-arm, Open-label Phase II Study

Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in approximately 2% of non-small-cell lung cancers. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This is a prospective, single-arm, open-label phase II study, designed to evaluate the efficacy and safety of pyrotinib combined with thalidomide in advanced non-small-cell lung cancer patients with HER2 exon 20 insertions.

Being tested
pyrotinib combined with thalidomide
Keywords
Pyrotinib, HER2, Non-small-cell Lung Cancer, Phase II, Thalidomide
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.

  • pyrotinib combined with thalidomideDrug

    Single Group Assignment

Study groups in NCT04382300
Study groupRoleWhat they receive
Treatment armExperimentalpyrotinib 400mg p.o. qd, combined with thalidomide 200mg p.o. qd
Receives: Drug: pyrotinib combined with thalidomide

What is being measured

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

  1. Objective Response Rate

    The proportion of patients with complete response or partial response.

    Measured: 24 months

Secondary outcomes (6)

  1. Progression-free Survival

    Time from the initiation of treatment to disease progression or death, whichever came first.

    Measured: 24 months

  2. Overall Survival

    Time from the initiation of treatment to death.

    Measured: 24 months

  3. Disease Control Rate

    The proportion of patients with complete response, partial response or stable disease.

    Measured: 24 months

  4. Incidence of Adverse Events

    Adverse events was graded according to NCI CTCAE 5.0.

    Measured: 24 months

  5. Changes in Scores of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)

    QLQ-C30 scores were standardized to a scale ranging from 0-100 by linear transformation. For global health status/quality of life and functional subscales, higher scores indicate a higher (better) level of function, whereas for the symptom subscales, higher scores indicate a higher (worse) severity of symptoms.

    Measured: 24 months

  6. Changes in Scores of EORTC Quality of Life Questionnaire-Lung Cancer Module 13 (QLQ-LC13)

    QLQ-LC13 scores were standardized to a scale ranging from 0-100 by linear transformation. For global health status/quality of life and functional subscales, higher scores indicate a higher (better) level of function, whereas for the symptom subscales, higher scores indicate a higher (worse) severity of symptoms.

    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 posted11 May 2020
  2. Study start30 Jun 2020
  3. Primary completionOct 2022 (estimated)
  4. Study completionApr 2023 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04382300
Sponsor's protocol ID
MA-NSCLC-II-005
Status last verified
Jan 2021
First submitted
30 Apr 2020
Last updated
28 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ai X, Song Z, Jian H, Zhou Z, Chen Z, Yu Y, Li Z, Lu S. Pyrotinib combined with thalidomide in advanced non-small-cell lung cancer patients harboring HER2 exon 20 insertions (PRIDE): protocol of an open-label, single-arm phase II trial. BMC Cancer. 2021 Sep 16;21(1):1033. doi: 10.1186/s12885-021-08759-8.

    PubMed 34530760

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pyrotinib combined with thalidomide in people with Non-small-cell Lung Cancer, run by Shanghai Chest Hospital 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 13 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 28 Jan 2021. 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 Shun Lu (86-21-22200000, shunlu@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (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 NCT04382300, 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 28 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in