A Phase II/III Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Nasopharyngeal Carcinoma

November 21, 2023 updated by: Qilu Pharmaceutical Co., Ltd.

A Randomized, Open, Multicenter Phase II/III Trial to Compare the Efficacy and Safety of QL1706 and Carrilizumab Combined With Gemcitabine and Cisplatin in First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

This is a randomized, open, multicenter phase II/III trial to compare the efficacy and safety of QL1706 and carrilizumab combined with gemcitabine and cisplatin in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, open, multicenter phase II/III trial to compare the efficacy and safety of QL1706 and carrilizumab combined with gemcitabine and cisplatin in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma. The study is divided into two parts.

The first part is a phase II, single-arm study with an introductory safety phase, which is planned to enroll 30 subjects with nasopharyngeal carcinoma treated with first-line QL1706 in combination with gemcitabine and cisplatin. The primary objective of the first part is to evaluate the safety and tolerability of QL1706 combined with gemcitabine and cisplatin in the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.

The second part is a phase III randomized, controlled study. The study plans to enroll 430 subjects, who will be randomized in a 1:1 ratio to a trial group of QL1706 in combination with gemcitabine and cisplatin and a control group of carrilizumab in combination with gemcitabine and cisplatin. The primary objective of the second part was to compare the effectiveness of QL1706 with that of carrilizumab combined with gemcitabine and cisplatin, respectively, in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

Study Type

Interventional

Enrollment (Estimated)

460

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The subject will participate voluntarily and sign the informed consent form.
  2. Age ≥ 18 years when signing the informed consent form, male or female.
  3. The Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or 1.
  4. Expected survival ≥ 3 months.
  5. Patients with pathologically confirmed nasopharyngeal carcinoma.
  6. Patients with primary diagnosis of metastatic nasopharyngeal carcinoma [stage IVb according to the American Joint Committee on Cancer AJCC staging system (8th edition)] or patients with recurrent (including recurrent or metastatic) nasopharyngeal carcinoma who are not candidates for radical surgery or radiotherapy or other local treatment; and for recurrent or metastatic lesions must be untreated systemically: previously treated with neoadjuvant chemotherapy with curative intent, Patients with adjuvant chemotherapy, radiotherapy or radiotherapy must have had ≥ 6 months between the last chemotherapy and or radiotherapy and the time of disease recurrence and/or development of metastases.
  7. Patients have at least one imaging measurable lesion according to RECISTv1.1 evaluation criteria; for lesions that have received prior radiotherapy or other local treatment there must be evidence of definite progression of the lesion after the end of local treatment in order to be selected as a measurable lesion.

  8. Adequate organ function prior to first use of the experimental drug (no blood components, leukocyte-raising drugs, or platelet-raising drugs are allowed within 7 days prior to obtaining laboratory tests)

    1. Absolute neutrophil count ≥ 1.5 x 109/L.
    2. Platelet count ≥ 100×109/L.
    3. Hemoglobin ≥ 90 g/L.
    4. Serum albumin ≥ 28 g/L.
  9. Subjects (both female and male) agree to use effective contraception from the time they sign the informed consent until 180 days after the last use of the trial drug. Women who are not pregnant or breastfeeding from the time they sign informed consent until 180 days after the last use of the trial drug.

Exclusion Criteria:

  1. Presence of symptomatic central nervous system (CNS) metastases, soft meningeal metastases, or spinal cord compression due to metastases.
  2. Prior systemic anticancer treatment with approved drugs or trial drugs.
  3. End date of palliative radiotherapy targeting bone metastases or soft tissue, etc. ≤ 7 days from imaging of baseline tumor lesions
  4. Presence of carcinomatous meningitis prior to first study treatment
  5. Active autoimmune disease present within 2 years prior to the first administration of the investigational drug and requiring systemic systemic therapy. Subjects with relevant alternative therapy who are stable are allowed to be included.
  6. Disease requiring systemic treatment with corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive drugs present within 2 weeks prior to first study treatment.
  7. At the investigator's discretion, have a serious concomitant condition that jeopardizes patient safety, or interferes with patient completion of the study, such as hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) not controlled by two or more antihypertensive medications, or severe diabetes mellitus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QL1706 Combined with Gemcitabine and Cisplatin
Drug: QL1706
5 mg/kg#D1#Q3W IV, 4-6 cycles
Drug: Gemcitabine
1000mg/m2#D1&D8#Q3W IV, 4-6 cycles
Drug: Cisplatin
80mg/m2#D1#Q3W IV, 4-6 cycles
Active Comparator: Carrilizumab Combined with Gemcitabine and Cisplatin
Drug: Gemcitabine
1000mg/m2#D1&D8#Q3W IV, 4-6 cycles
Drug: Cisplatin
80mg/m2#D1#Q3W IV, 4-6 cycles
Drug: Carrelizumab
200mg#D1#Q3W IV, 4-6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS) -BICR
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered
The PFS assessed by Blinded independent central review (BICR)
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS- Investigator
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered
The PFS assessed by Investigator
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered
Objective remission rate (ORR)
Time Frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks
The ORR assessed by BICR and Investigator
Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks
Duration of remission (DOR)
Time Frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks
The DOR assessed by BICR and Investigator
Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks
Disease Control Rate (DCR)
Time Frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks
The DCR assessed by BICR and Investigator
Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks
Overall survival (OS)
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered
Overall survival
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered
12-month OS rate
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered
12-month Overall survival rate
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Li Zhang, Doctor, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

October 7, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QL1706-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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