151 Participants Needed

Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy

(PYRAMID-1 Trial)

Recruiting at 103 trial locations
CZ
HL
YW
Overseen ByYueling Wang
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing pyrotinib, an oral medication, in patients with advanced non-squamous NSCLC who have a HER2 exon 20 mutation and did not respond to previous chemotherapy. Pyrotinib aims to block proteins that help cancer cells grow. It was approved in China for HER2-positive breast cancer and has shown promising antitumor activity against HER2-mutant NSCLC.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take certain drugs that affect how the study drugs work, like strong CYP3A4 inducers or inhibitors, P-gp inhibitors, or medications that cause QT/QTc prolongation.

What data supports the effectiveness of the drug Docetaxel?

Docetaxel has shown impressive results in treating various cancers, including breast, lung, ovarian, prostate, head and neck, gastric, and bladder cancers. It has been found to be as effective or superior to standard treatments, often with a better safety profile, and has demonstrated a survival benefit in several settings.12345

What safety data exists for Docetaxel (Taxotere) in humans?

Docetaxel, also known as Taxotere, has been studied for safety in various cancers. Common side effects include neutropenia (low white blood cell count), hair loss, skin reactions, and fluid retention. In some cases, it has been associated with scleroderma-like illness, a condition affecting the skin and connective tissues.16789

What makes the drug combination of Docetaxel and Pyrotinib unique?

The combination of Docetaxel and Pyrotinib is unique because Docetaxel is a well-known chemotherapy drug that stabilizes microtubules to prevent cancer cell division, while Pyrotinib is a newer drug that targets specific proteins involved in cancer growth. This combination may offer a novel approach by attacking cancer cells through different mechanisms, potentially improving treatment effectiveness.46101112

Research Team

WS

Wei Shi, MD,PhD

Principal Investigator

Jiangsu Hengrui Pharmaceuticals Co.,Ltd

Eligibility Criteria

Inclusion Criteria

ECOG PS 0-1.
Signed and dated written informed consent which is approved by IRB/EC, willing and able to comply with scheduled treatment, all examinations at study visits, and other study procedures.
Have histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC disease.
See 5 more

Exclusion Criteria

Malignant tumors with other pathological types.
Medical history of other active malignancies within last 5 years.
Prior to the first dose of study treatment, patients with severe effusions with clinical symptoms, severe cardiac disease, or severe infection.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pyrotinib or docetaxel monotherapy in 21-day cycles

52 weeks
Tumor assessments every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

Survival Follow-up

Participants are followed for survival every 56 days until death or study termination

36 months

Treatment Details

Interventions

  • Docetaxel
  • Pyrotinib
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Study treatment ArmExperimental Treatment1 Intervention
Pyrotinib maleate tablet, 400 mg, once daily (QD)
Group II: Control ArmActive Control1 Intervention
Docetaxel injection, 75 mg/m2, once every 3 weeks (Q3W)

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Taxotere for:
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Prostate Cancer
🇪🇺
Approved in European Union as Taxotere for:
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Prostate Cancer
🇨🇦
Approved in Canada as Taxotere for:
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Prostate Cancer
🇯🇵
Approved in Japan as Taxotere for:
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Prostate Cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jiangsu HengRui Medicine Co., Ltd.

Lead Sponsor

Trials
663
Recruited
102,000+
Founded
1970
Headquarters
Lianyungang, China
Known For
Oncology Innovations
Top Products
Camrelizumab, Rivoceranib (Apatinib)

Findings from Research

Docetaxel has shown impressive efficacy in treating various cancers, including breast cancer, non-small-cell lung cancer (NSCLC), and ovarian cancer, outperforming or matching established chemotherapy regimens in phase III trials involving multiple tumor types.
In addition to its effectiveness, docetaxel is often associated with an improved safety profile, and it has demonstrated a survival benefit in previously challenging cases, such as anthracycline-resistant breast cancer and second-line NSCLC.
The current status of docetaxel in solid tumors. An M. D. Anderson Cancer Center Review.Hong, WK.[2018]
In a Phase IV study involving 411 Iranian cancer patients, docetaxel (Alvotere) demonstrated an acceptable safety profile, with alopecia being the most common adverse event reported in 41.12% of patients.
The study found that 22.38% of patients experienced severe adverse events (grade 3 or 4), with a notable difference in skin disorders between genders, indicating the need for careful monitoring during treatment.
A Post-Marketing Surveillance Study to Evaluate the Safety Profile of AlvotereⓇ (Docetaxel) in Iranian Patients Diagnosed with Different Types of Cancers Receiving Chemotherapy.Shahi, F., Vafaeezadeh, F., Ansarinejad, N., et al.[2022]
In a study of 170 patients with advanced non-small cell lung cancer, those treated with EGFR-TKIs as second-line therapy showed the highest response rate (36.1%) and the longest progression-free survival (PFS) of 9.31 months, compared to 15.0% response rate and 5.49 months PFS for docetaxel and 24.5% response rate and 5.42 months PFS for pemetrexed.
All three treatments (docetaxel, pemetrexed, and EGFR-TKIs) had comparable safety profiles, but there was no significant difference in median survival time (MST) among the groups, indicating that while EGFR-TKIs may offer better short-term benefits, long-term survival outcomes were similar across treatments.
[Efficacy and safety of docetaxol, pemetrexed and EGFR-TKIs as second-line treatment for patients with advanced non-small-cell lung cancer].Zhang, RX., Cai, DY., Wu, XH., et al.[2018]

References

The current status of docetaxel in solid tumors. An M. D. Anderson Cancer Center Review. [2018]
Docetaxel (Taxotere) in the treatment of solid tumors other than breast and lung cancer. [2018]
A Post-Marketing Surveillance Study to Evaluate the Safety Profile of AlvotereⓇ (Docetaxel) in Iranian Patients Diagnosed with Different Types of Cancers Receiving Chemotherapy. [2022]
Docetaxel. [2021]
[Efficacy and safety of docetaxol, pemetrexed and EGFR-TKIs as second-line treatment for patients with advanced non-small-cell lung cancer]. [2018]
Dose intensity and toxicity associated with Taxotere formulation: a retrospective study in a population of breast cancer patients treated with docetaxel as an adjuvant or neoadjuvant chemotherapy. [2018]
Phase II study of docetaxel for recurrent or metastatic non-small-cell lung cancer. [2018]
Scleroderma in association with the use of docetaxel (taxotere) for breast cancer. [2018]
Docetaxel: a tubulin-stabilizing agent approved for the management of several solid tumors. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Docetaxel (Taxotere) associated scleroderma-like changes of the lower extremities. A report of three cases. [2019]
Enhancement of docetaxel solubility using binary and ternary solid dispersion systems. [2022]
[Docetaxel (taxotere): current status of clinical development in non-small-cell bronchial carcinoma (NSCLC)]. [2019]