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QL1706 Plus Anlotinib as a Later-line Treatment for Patients With Advanced Lung Cancer

ConditionSmall Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSun Yat-sen University

About this trial

This is a multicenter, open-label, randomized controlled phase II/III study evaluating the efficacy and safety of QL1706 in combination with anlotinib as later-line treatment in patients with advanced lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Male or female patients aged 18 years and above, up to 80 years old. 2. Small cell lung cancer or lung squamous cell carcinoma confirmed by tissue or pathological examination.

Absolute neutrophil count ≥ 1,500/mcL

Platelet count > 90,000/mcL

Hemoglobin ≥ 9 g/dL (allowing for Hgb transfusion)

Disqualifiers

1. Patients with symptomatic central nervous system metastases, or those with unstable neurological symptoms requiring an increase in the dosage of corticosteroids.

Trial design

Design model

Parallel

Treatments tested in this trial

  • QL1706

    Drug

    Every 3 weeks, 5mg/kg of QL1706 is administered intravenously until the disease progresses.

  • Anlotinib

    Drug

    10mg Anlotinib is administered orally. It is given daily for the first 14 days, then stopped for 7 days. A 3-week period constitutes one cycle, and this process continues until the disease progresses.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: cohort 1Experimental treatment 2 interventions
Group B: cohort 2Active comparator 1 intervention
Group C: cohort 3Experimental treatment 2 interventions
Group D: cohort 4Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

OS

Overall survival (OS), defined as the time from first study treatment to death from any cause.

Time frame
From date of first study treatment to date of death from any cause, assessed up to approximately 36 months

Secondary outcomes

1

PFS

Progression-free survival (PFS) is defined as the time from the first trial treatment to disease progression or death due to any cause (whichever occurs first).

Time frame
From date of first study treatment to the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to approximately 36 months.
2

DCR

Disease Control Rate (DCR), the proportion of patients achieving the best overall therapeutic response of CR, PR or SD

Time frame
From first study treatment to disease progression or initiation of new anti-tumor therapy, assessed up to approximately 36 months
3

12-months OS rate

The 12-month overall survival rate is defined as the proportion of patients who remain alive 12 months after the first trial treatment.

Time frame
From date of first study treatment to date of death from any cause, assessed up to 12 months
4

Adverse Events

Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Relationship to study treatment (QL1706 and/or anlotinib) is assessed by the investigator.

Time frame
From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: