Non-squamous Non-small Cell Lung CancerPhase 3NCT03169335
Efficacy and Safety of QL1101 and Avastin® Respectively Combined With Paclitaxel and Carboplatin in the First-line Treatment of Non-squamous Non-small Cell Lung Cancer
A Phase 3 study testing QL1101, Avastin® and Paclitaxel in people with Non-squamous Non-small Cell Lung Cancer, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
The objective of this study is to assess the similarity between QL1101 and Avastin® respectively combined with chemotherapy in terms of efficacy and safety in patients with non-squamous non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- QL1101, Avastin® and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 535 participants
- Where
- 2 sitesChina
- Study dates
- 28 Mar 2017to 13 Jul 2018
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years and ≤75 years; 2) Patients with histologically or cytologically confirmed inoperable locally advanced (Stage IIIb, not suitable for multidisciplinary treatment), metastatic (Stage IV), or relapsed non-squamous cell non-small cell lung cancer. Diagnostic result of non-squamous cell non-small cell lung cancer obtained based on sputum cytology should be immunohistochemically confirmed. If a variety of tumor ingredients are mixed, the main cell types should be classified;
- ECOG score of 0-1 points;
- At least one measurable lesion can be evaluated according to RECIST1.1 criteria; Lesions situated in a previously irradiated area are considered measurable only if marked progressive signs occur after irradiation
- Patients who have not received systemic anti-tumor therapy of locally advanced or metastatic non-squamous non-small cell lung cancer (if the subject received adjuvant therapy after completing the radical treatment of early non-small cell lung cancer, but then the disease relapsed, the subject can be enrolled. In this case, the end time of the adjuvant therapy is required to be more than 6 months from the time of the first administration of this study, and various toxic reactions resulting from the adjuvant therapy should have recovered (≤ Grade 1 by CTCAE 4.03 criteria, except for alopecia).
- Expected survival time ≥24 weeks.
- Subjects must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form.
Who cannot join
- Central squamous cell carcinoma, and mixed gland squamous cell carcinoma with squamous cell as the main ingredient;
- ALK fusion gene is known to be positive;
- Medical history or examination shows thrombotic disease within 6 months prior to screening;
- Imaging shows signs of tumor invasion of large vessels, and the investigator or radiologist must exclude patients whose tumor has been completely close to or surrounded or invaded the lumen of large vessels (e.g., the superior pulmonary artery or superior vena cava);
- Patients with a past history of symptomatic brain metastases or meningeal metastases, or spinal cord compression;
- Patients who received palliative radiotherapy for bone lesions outside the chest within 2 weeks prior to the first dose of the study drug;
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- Patients who received major surgical procedures (including thoracotomy), or suffered from major trauma (such as fractures) within 28 days prior to screening, or need to undergo major surgery during the expected study treatment period;
- Patients who received a minor surgical procedure within 48 hours prior to the first treatment with Anivitis®/QL1101 (the investigator judges whether there is bleeding tendency);
- Patients who are currently using or have recently used (within 10 days prior to the first dose of Avastin®/QL1101) aspirin (>325 mg/day) or other nonsteroidal antiinflammatory drugs known to inhibit platelet function, or full-dose anticoagulants;
- Patients whose medical history or examination shows hereditary bleeding tendency or coagulation disorders, which may increase the risk of bleeding; -Uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg);
- Patients who had a past history of hypertensive crisis or hypertensive encephalopathy;
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel, Two-group Phase III Clinical Study of the Efficacy and Safety of QL1101 and Avastin® Respectively Combined With Paclitaxel and Carboplatin in the First-line Treatment of Non-squamous Non-small Cell Lung Cancer
The objective of this study is to assess the similarity between QL1101 and Avastin® respectively combined with chemotherapy in terms of efficacy and safety in patients with non-squamous non-small cell lung cancer. The study intends to include first-line patients with non-squamous non-small cell lung cancer, and uses QL1101 combined with basic chemotherapy CP (paclitaxel + carboplatin). The regimen is consistent with the usage and dosage of Avastin® at home and abroad indicated for the treatment of non-squamous non-small cell lung cancer.
Read the detailed description
The study is a randomized, double-blind, positive drug-controlled, multi-center Phase III study. It is planned to enroll 512 treatment-naïve patients with non-squamous non-small cell lung cancer (NSCLC). Subjects are randomized into the QL1101 combined with paclitaxel/carboplatin or Avastin® combined with paclitaxel/carboplatin treatment group by a ratio of 1:1, and stratified by age (≥65 years, <65 years), sex (male, female) and EGFR subtype (sensitive mutation type, wild type).
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- QL1101, Avastin®, Paclitaxel, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1101Drug
targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
Avastin®Drug
Also called bevacizumab
targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
PaclitaxelDrug
175 mg/m2, IV (in the vein) following investigational product on day 1 of each 21 day cycle. Number of cycles 4-6.
CarboplatinDrug
AUC 5 IV, (in the vein) following paclitaxel on day 1 of each 21 day cycle. Number of cycles: 4-6.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | QL1101 + paclitaxel/carboplatin:subjects are given 15 mg/kg QL1101 on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles (at least 4 cycles). Receives: Drug: QL1101; Drug: Paclitaxel; Drug: Carboplatin |
| Control group | Active comparator | Avastin® + paclitaxel/carboplatin:subjects are given 15 mg/kg Avastin® on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles (at least 4 cycles). Receives: Drug: Avastin®; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The actual endpoint is best response seen during the study
Measured: 18 weeks
Secondary outcomes (4)
Disease control rate
DOR is defined as the time from the first tumor evaluation as CR or PR to the first evaluation as PD or death
Measured: 3 months, 6 months, 9 months, 1 year
Overall survival (OS)
OS is defined as the time from randomization and grouping to patient death due to various causes. For patients who are lost to follow-up, the date when they were contacted for the last time will be used as the cut off time.
Measured: 18 months after enrollment and randomization of the last case
Progression-free survival (PFS)
PFS is defined as the time from randomization and grouping to PD or death.
Measured: 18 months after enrollment and randomization of the last case
Treatment-emergent adverse events
Assessment following therapy with either QL1101 or avastin
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start28 Mar 2017
- Primary completion23 Jun 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169335
- Sponsor's protocol ID
- QL1101-002
- Status last verified
- May 2017
- First submitted
- 23 May 2017
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel, Two-group Phase III Clinical Study of the Efficacy and Safety of QL1101 and Avastin® Respectively Combined With Paclitaxel and Carboplatin in the First-line Treatment of Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03169335
- Acronym / sponsor ID
- QL1101-002
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 23 Jun 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the similarity between QL1101 and Avastin® respectively combined with chemotherapy in terms of efficacy and safety in patients with non-squamous non-small cell lung cancer. The study intends to include first-line patients with non-squamous non-small cell lung cancer, and uses QL1101 combined with basic chemotherapy CP (paclitaxel + carboplatin). The regimen is consistent with the usage and dosage of Avastin® at home and abroad indicated for the treatment of non-squamous non-small cell lung cancer.
Detailed description
The study is a randomized, double-blind, positive drug-controlled, multi-center Phase III study. It is planned to enroll 512 treatment-naïve patients with non-squamous non-small cell lung cancer (NSCLC). Subjects are randomized into the QL1101 combined with paclitaxel/carboplatin or Avastin® combined with paclitaxel/carboplatin treatment group by a ratio of 1:1, and stratified by age (≥65 years, <65 years), sex (male, female) and EGFR subtype (sensitive mutation type, wild type).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: QL1101, Drug: Paclitaxel, Drug: CarboplatinQL1101 + paclitaxel/carboplatin:subjects are given 15 mg/kg QL1101 on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles (at least 4 cycles). |
| Control group | Active comparator | Drug: Avastin®, Drug: Paclitaxel, Drug: CarboplatinAvastin® + paclitaxel/carboplatin:subjects are given 15 mg/kg Avastin® on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles (at least 4 cycles). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥18 years and ≤75 years; 2) Patients with histologically or cytologically confirmed inoperable locally advanced (Stage IIIb, not suitable for multidisciplinary treatment), metastatic (Stage IV), or relapsed non-squamous cell non-small cell lung cancer. Diagnostic result of non-squamous cell non-small cell lung cancer obtained based on sputum cytology should be immunohistochemically confirmed. If a variety of tumor ingredients are mixed, the main cell types should be classified;
- ECOG score of 0-1 points;
- At least one measurable lesion can be evaluated according to RECIST1.1 criteria; Lesions situated in a previously irradiated area are considered measurable only if marked progressive signs occur after irradiation
- Patients who have not received systemic anti-tumor therapy of locally advanced or metastatic non-squamous non-small cell lung cancer (if the subject received adjuvant therapy after completing the radical treatment of early non-small cell lung cancer, but then the disease relapsed, the subject can be enrolled. In this case, the end time of the adjuvant therapy is required to be more than 6 months from the time of the first administration of this study, and various toxic reactions resulting from the adjuvant therapy should have recovered (≤ Grade 1 by CTCAE 4.03 criteria, except for alopecia).
- Expected survival time ≥24 weeks.
Key exclusion criteria (11 listed)
- Central squamous cell carcinoma, and mixed gland squamous cell carcinoma with squamous cell as the main ingredient;
- ALK fusion gene is known to be positive;
- Medical history or examination shows thrombotic disease within 6 months prior to screening;
- Imaging shows signs of tumor invasion of large vessels, and the investigator or radiologist must exclude patients whose tumor has been completely close to or surrounded or invaded the lumen of large vessels (e.g., the superior pulmonary artery or superior vena cava);
- Patients with a past history of symptomatic brain metastases or meningeal metastases, or spinal cord compression;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1101targeted vascular endothelial growth factor (VEGF) monoclonal antibodies | Drug | Experimental group |
| Avastin®Also: bevacizumabtargeted vascular endothelial growth factor (VEGF) monoclonal antibodies | Drug | Control group |
| Paclitaxel175 mg/m2, IV (in the vein) following investigational product on day 1 of each 21 day cycle. Number of cycles 4-6. | Drug | Control group, Experimental group |
| CarboplatinAUC 5 IV, (in the vein) following paclitaxel on day 1 of each 21 day cycle. Number of cycles: 4-6. | Drug | Control group, Experimental group |
Primary outcome
Objective response rate
Time frame: 18 weeks
The actual endpoint is best response seen during the study
4 secondary outcomes
Disease control rate
Time frame: 3 months, 6 months, 9 months, 1 year
Overall survival (OS)
Time frame: 18 months after enrollment and randomization of the last case
Progression-free survival (PFS)
Time frame: 18 months after enrollment and randomization of the last case
Treatment-emergent adverse events
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QL1101, Avastin® and Paclitaxel in people with Non-squamous Non-small Cell Lung Cancer, run by Qilu Pharmaceutical Co., Ltd. at 2 sites 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2018.