Carcinoma, Non-Small-Cell LungPhase 2NCT04023617
A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic NSCLC
A Phase 2 study testing Nivolumab in people with Carcinoma, Non-Small-Cell Lung and Docetaxel, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study is a randomized, single-center, open-label, phase II clinical trial designed to evaluate non-small cell lung cancer that has failed to undergo excessive platinum-based chemotherapy and has not received excessive statin chemotherapy and has not received immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Docetaxel, Nivolumab
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2019to 30 May 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men \& women ≥18, and ≤75 years of age.
- Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second line of treatment for advanced disease.
- The patient's tumor must be free of EGFR gene-sensitive mutations (including but not limited to exon 19 deletion mutation or exon 21 L858R mutation, exon 21 L861Q, exon 18 G719X or exon 20 S768I site Mutation) and ALK gene rearrangement. If the pathology is squamous cell carcinoma or the tumor of a known patient has a KRAS mutation, then EGFR and ALK are not required to be detected.
- Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease.
- Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
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- Expected survival time ≥ 12 weeks.
- Has adequate organ and bone marrow function, defined as follows:
- Hemoglobin ≥ 9.0 g/dL.
- Absolute neutrophil count ≥1.5 × 109 /L.
- Platelet count ≥80 × 109 /L.
- Serum total bilirubin ≤ 1.5 × normal upper limit (ULN); for patients with liver metastasis, serum total bilirubin ≤ 5 × normal upper limit (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases: ALT and AST ≤ 5 × ULN.
- Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal (ULN).
- Pre-menopausal women have a negative urine or serum pregnancy test within 14 days prior to initiation of treatment.
- Written informed consent was signed prior to the experiment.
Who cannot join
- Have been treated with docetaxel or have previously received immunological checkpoint inhibitors targeting PD-1, PD-L1 or CTLA-4.
- Prior to randomization ≤ 21 days (or ≤ 5 half-lives, whichever is shorter) have received chemotherapy, other test drugs, and Chinese herbal medicines used to control cancer.
- Uncontrolled brain metastases and all meningeal metastases. Stereotactic radiotherapy within 7 days prior to the start of treatment in the first cycle, or brain metastases who underwent whole brain radiotherapy within the first 14 days (if the patient detected a new asymptomatic CNS metastasis during the screening scan, then radiotherapy must be received) And/or central nervous system metastases. After treatment, these patients do not require additional brain scans to enter the trial if other inclusion criteria are met.
- Large area radiotherapy (except for local palliative radiotherapy for bones).
- Pericardial effusion, pleural effusion, or ascites that is clinically uncontrolled and requires pericardial puncture, thoracic puncture, or abdominal puncture drainage within 2 weeks of randomization.
- A history of malignancy other than NSCLC within the first 5 years of randomization, except for malignant tumors with a very low risk of metastatic death and expected to heal after treatment (eg fully treated cervical carcinoma in situ, basal or squamous cell skin cancer, accepted Localized prostate cancer for radical treatment, ductal carcinoma in situ for radical surgery).
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- Have undergone major surgery (as defined by the investigator) within 28 days prior to the first dose. Note: For the purpose of palliative care, local surgical treatment of isolated lesions is acceptable.
- Any condition that, depending on the investigator's judgment, interferes with the evaluation of the efficacy of the study drug or explains the patient's safety or findings, including but not limited to: persistent or active infection, symptomatic congestive heart failure, poorly controlled hypertension, Unstable angina, arrhythmia, or psychiatric/social conditions that affect the study's requirements, significantly increase the risk of AEs in the study drug, or affect the patient's ability to provide informed consent.
- Active or previously documented autoimmune or inflammatory disease (with vitiligo, hypothyroidism (after Hashimoto's syndrome) and stable disease after hormone replacement therapy, no active disease in the past 5 years Patients can be enrolled).
- Active infections, including tuberculosis, hepatitis B, and hepatitis C.
Trial locations and contacts
1 site in 1 country.
Jie Zhang contact
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jian Fang, +86-010-88196459, bcht2_mj@163.com
Di Wu, +86-010-88196459, lucia8810@sina.com
About this study
Official title: A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer
This study is a randomized, single-center, open-label, phase II clinical trial designed to evaluate non-small cell lung cancer that has failed to undergo excessive platinum-based chemotherapy and has not received excessive statin chemotherapy and has not received immunotherapy. The efficacy and safety of Nivolumab in combination with docetaxel and Nivolumab in patients.
Qualified patients were stratified by histological type (squamous cell carcinoma vs. non-squamous cell carcinoma) randomized to receive the following regimen in a 1:1 ratio:
Group A: Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Group B: Nivolumab 200mg IV q2w All patients were evaluated for tumor at baseline, and tumor evaluations were performed every 6 weeks within 48 weeks after randomization (regardless of whether dosing was delayed). After the 48th week of assessment, a tumor assessment is required every 9 weeks until disease progression, withdrawal of informed consent, sponsor termination study, or patient death.
Read the detailed description
Nivolumab and Docetaxel have been approved as standard second-line treatments for non-small cell lung cancer in several countries including China and the United States.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Docetaxel, Nivolumab
- Being tested
- Nivolumab
- 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.
NivolumabDrug
Also called docetaxel
Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Nivolumab 200mg IV q2w
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab + Docetaxel | Experimental | Nivolumab was administered at a dose of 300 mg on the first day of the 21-day cycle (every 3 weeks; q3w) when combined with docetaxel, and administered at a dose of 200 mg on the first day of each 14-day cycle (every 2 weeks; q2w) after stopping docetaxel treatment.
On the first day of each cycle (21 days), docetaxel 75 mg/m2 was infused by IV on Day 1 of each 21-day cycle for 4-6 cycles (judged by investigator). Receives: Drug: Nivolumab |
| Nivolumab | Active comparator | Nivolumab was administered in the monotherapy group at a dose of 200 mg on the first day of each 14-day cycle (every 2 weeks; q2w). Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: 24 months
Secondary outcomes (1)
OS
overall survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start8 Jul 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Fang, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023617
- Sponsor's protocol ID
- NIDO-101
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04023617
- Acronym / sponsor ID
- NIDO-101
- Conditions
- Carcinoma, Non-Small-Cell Lung, Docetaxel, Nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 17 Jul 2019 (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.
This study is a randomized, single-center, open-label, phase II clinical trial designed to evaluate non-small cell lung cancer that has failed to undergo excessive platinum-based chemotherapy and has not received excessive statin chemotherapy and has not received immunotherapy. The efficacy and safety of Nivolumab in combination with docetaxel and Nivolumab in patients.
Qualified patients were stratified by histological type (squamous cell carcinoma vs. non-squamous cell carcinoma) randomized to receive the following regimen in a 1:1 ratio:
Group A: Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Group B: Nivolumab 200mg IV q2w All patients were evaluated for tumor at baseline, and tumor evaluations were performed every 6 weeks within 48 weeks after randomization (regardless of whether dosing was delayed). After the 48th week of assessment, a tumor assessment is required every 9 weeks until disease progression, withdrawal of informed consent, sponsor termination study, or patient death.
Detailed description
Nivolumab and Docetaxel have been approved as standard second-line treatments for non-small cell lung cancer in several countries including China and the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab + Docetaxel | Experimental | Drug: NivolumabNivolumab was administered at a dose of 300 mg on the first day of the 21-day cycle (every 3 weeks; q3w) when combined with docetaxel, and administered at a dose of 200 mg on the first day of each 14-day cycle (every 2 weeks; q2w) after stopping docetaxel treatment. On the first day of each cycle (21 days), docetaxel 75 mg/m2 was infused by IV on Day 1 of each 21-day cycle for 4-6 cycles (judged by investigator). |
| Nivolumab | Active comparator | Drug: NivolumabNivolumab was administered in the monotherapy group at a dose of 200 mg on the first day of each 14-day cycle (every 2 weeks; q2w). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men \& women ≥18, and ≤75 years of age.
- Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second line of treatment for advanced disease.
- The patient's tumor must be free of EGFR gene-sensitive mutations (including but not limited to exon 19 deletion mutation or exon 21 L858R mutation, exon 21 L861Q, exon 18 G719X or exon 20 S768I site Mutation) and ALK gene rearrangement. If the pathology is squamous cell carcinoma or the tumor of a known patient has a KRAS mutation, then EGFR and ALK are not required to be detected.
- Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease.
- Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria.
Key exclusion criteria (10 listed)
- Have been treated with docetaxel or have previously received immunological checkpoint inhibitors targeting PD-1, PD-L1 or CTLA-4.
- Prior to randomization ≤ 21 days (or ≤ 5 half-lives, whichever is shorter) have received chemotherapy, other test drugs, and Chinese herbal medicines used to control cancer.
- Uncontrolled brain metastases and all meningeal metastases. Stereotactic radiotherapy within 7 days prior to the start of treatment in the first cycle, or brain metastases who underwent whole brain radiotherapy within the first 14 days (if the patient detected a new asymptomatic CNS metastasis during the screening scan, then radiotherapy must be received) And/or central nervous system metastases. After treatment, these patients do not require additional brain scans to enter the trial if other inclusion criteria are met.
- Large area radiotherapy (except for local palliative radiotherapy for bones).
- Pericardial effusion, pleural effusion, or ascites that is clinically uncontrolled and requires pericardial puncture, thoracic puncture, or abdominal puncture drainage within 2 weeks of randomization.
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 |
|---|---|---|
| NivolumabAlso: docetaxelNivolumab 300mg + docetaxel 75mg/m2 IV q3w Nivolumab 200mg IV q2w | Drug | Nivolumab, Nivolumab + Docetaxel |
Primary outcome
PFS
Time frame: 24 months
progression-free survival
1 secondary outcome
OS
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
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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.
Jie Zhang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with Carcinoma, Non-Small-Cell Lung and Docetaxel, run by Peking University Cancer Hospital & Institute 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 16 inclusion and 10 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 17 Jul 2019. 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 Yang Wang, M.D. (86-010-88196478, xmwangyang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 24 months). 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 17 Jul 2019.