Non-Small Cell Lung CancerPhase 3NCT02643407
Nedaplatin/Docetaxel Versus Cisplatin/Docetaxel in Treatment of Advanced/Relapsed Squamous Cell Lung Cancer
A Phase 3 study testing Docetaxel, Nedaplatin and Cisplatin in people with Non-Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 1 site in China.
Trial summary
To compare the efficacy and safety of docetaxel plus nedaplatin with docetaxel plus cisplatin in managment of advanced/relapsed squamous cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Docetaxel, Nedaplatin and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Dec 2017
- 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
- Patients were required to be between 18 to 75 years, with histologically or cytologically proven squamous cell carcinoma of the lung, stage ⅢB (unfit for definitive radiotherapy), stage Ⅳ or relapsing;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of zero or one;
- life expectancy > 3 months;
- No previous history of malignancy (except adequately treated carcinoma-in-situ of the cervix or basal cell carcinoma of the skin or superficial bladder cancer [Ta, Tis \& T1]); previously untreated with chemotherapy (eg. gemcitabine, platinum, paclitaxel); no previously systemic therapy on locally advanced and metastatic disease; patients were eligible for participation in the study if they had recurrence or metastasis and became locally advanced or metastatic lung cancer after 12 months treatment with gemcitabine, platinum or paclitaxel regimen in adjuvant or neoadjuvant chemotherapy;
- Adequate organ function was required, as evidenced by absolute neutrophil count ≥ 1.5 x 109 /L, platelet count ≥ 100 x109/L, hemoglobin ≥ 90 g/L (9 g/dL);
- hepatic enzyme levels ≤ 2.5 x the upper limit of the normal range (ULN), alkaline phosphatase levels ≤ 5.0 x the ULN, total bilirubin levels ≤ 1.5 x the ULN, and serum creatinine levels ≤1.5 mg/dL (or creatinine clearance ≥50 mL/min);
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- Previous radiotherapy was allowed if it involved <25% of bone marrow and was completed 4 weeks before study entry; Patients must be recovered from acute toxicity before the clinical trials;
- Pregnancy test: negative (female only); Women with fertility need pregnancy test (serum or urine) in 7 days before entering the group and the results were negative. Male or female patients with reproduction potential had to use an approved contraceptive method during and for 8 weeks after the end of study treatment.
- Patients are judged by researcher to be the compliance of research requirements and follow-up.
- All the patients provided their written informed consent before enrollment.
- The standard first-line platinum-based regimens according to the clinical practice, and the efficacy was evaluated every two cycles.
Who cannot join
- EGFR positive or ALK positive (patients, the status of EGFR and ALK were unknown due to the detection, were included);
- Participation in any clinical research in 4 weeks before the first dosage, except non interventional epidemiological investigation;
- Patients with the complications in high risk;
- Primary brain tumors or central nervous system (CNS) metastatic carcinoma. The patients who are suspected the CNS metastatic carcinoma should be scanned in 28 days before entering the group. Other malignant disease five years ago (except cone-biopsied carcinoma-in-situ of the cervix or adequately treated basal or squamous cell carcinoma of the skin)
- Third-space fluid collection that has the clinical significance, such as ascites or pleural effusion, cannot control through the drainage or other method;
- Serious mental retardation or cognitive impairment, psychotic illness, poor compliance, cannot meet and narrate therapy responders;
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- No eliminated acute or chronic infection, or other serious concomitant diseases;
- Serious or uncontrolled concomitant disorders (active infection, ischemic heart diseases, arrhythmia, liver dysfunction, or peripheral nerve disorder);
- Patients with bleeding tendency or organ transplant;
- Alcohol or drug dependent patients; patients with the chronic administration of adrenal cortical hormone or immunosuppressive; patients with AIDS or other infectious diseases;
- Active hepatitis, liver metastasis is over 3/4 of the whole liver;
- A history of drug allergy;
- The female patients in the reproductive years are unwilling contraception;
- Accept other anti-tumor therapy at the same time;
- The researchers believe that the patients are not able to complete the entire clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080
Haiyan Tu, MD, +86 20 83827812 ext. 50810, thoraciconcology88@163.com
Yi-Long Wu, MD, +86 20 83827812 ext. 51221, syylwu@live.cn
About this study
Official title: Nedaplatin/Docetaxel Versus Cisplatin/Docetaxel in Treatment of Advanced/Relapsed Squamous Cell Lung Cancer :A Randomized, Open, Parallel, Multicentre, Phase Ⅲ Study
To compare the efficacy and safety of docetaxel plus nedaplatin with docetaxel plus cisplatin in managment of advanced/relapsed squamous cell lung cancer.
Read the detailed description
This study is prospective to evaluate whether the efficacy and safety of docetaxel plus nedaplatin is non-inferior to docetaxel plus cisplatin in managment of advanced/relapsed squamous cell lung cancer.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- squamous cell carcinoma, nedaplatin, cisplatin, docetaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel plus Nedaplatin | Experimental | docetaxel 60mg/m2 and nedaplatin 80mg/m2, d1 every 3 weeks Receives: Drug: Docetaxel; Drug: Nedaplatin |
| Docetaxel plus Cisplatin | Active comparator | docetaxel 60mg/m2 and cisplatin 75mg/m2, d1 every 3 weeks Receives: Drug: Docetaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Long Wu, Guangdong Association of Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643407
- Sponsor's protocol ID
- CTONG1501
- Status last verified
- Dec 2015
- First submitted
- 29 Dec 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li T, Kung HJ, Mack PC, Gandara DR. Genotyping and genomic profiling of non-small-cell lung cancer: implications for current and future therapies. J Clin Oncol. 2013 Mar 10;31(8):1039-49. doi: 10.1200/JCO.2012.45.3753. Epub 2013 Feb 11.
PubMed 23401433Mitsudomi T, Yatabe Y. Mutations of the epidermal growth factor receptor gene and related genes as determinants of epidermal growth factor receptor tyrosine kinase inhibitors sensitivity in lung cancer. Cancer Sci. 2007 Dec;98(12):1817-24. doi: 10.1111/j.1349-7006.2007.00607.x. Epub 2007 Sep 20.
PubMed 17888036Soda M, Choi YL, Enomoto M, Takada S, Yamashita Y, Ishikawa S, Fujiwara S, Watanabe H, Kurashina K, Hatanaka H, Bando M, Ohno S, Ishikawa Y, Aburatani H, Niki T, Sohara Y, Sugiyama Y, Mano H. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature. 2007 Aug 2;448(7153):561-6. doi: 10.1038/nature05945. Epub 2007 Jul 11.
PubMed 17625570Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.
PubMed 11784875Hoang T, Dahlberg SE, Schiller JH, Johnson DH. Does histology predict survival of advanced non-small cell lung cancer patients treated with platin-based chemotherapy? An analysis of the Eastern Cooperative Oncology Group Study E1594. Lung Cancer. 2013 Jul;81(1):47-52. doi: 10.1016/j.lungcan.2013.03.018. Epub 2013 Apr 21.
PubMed 23611404Fossella F, Pereira JR, von Pawel J, Pluzanska A, Gorbounova V, Kaukel E, Mattson KV, Ramlau R, Szczesna A, Fidias P, Millward M, Belani CP. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol. 2003 Aug 15;21(16):3016-24. doi: 10.1200/JCO.2003.12.046. Epub 2003 Jul 1.
PubMed 12837811Tan EH, Rolski J, Grodzki T, Schneider CP, Gatzemeier U, Zatloukal P, Aitini E, Carteni G, Riska H, Tsai YH, Abratt R. Global Lung Oncology Branch trial 3 (GLOB3): final results of a randomised multinational phase III study alternating oral and i.v. vinorelbine plus cisplatin versus docetaxel plus cisplatin as first-line treatment of advanced non-small-cell lung cancer. Ann Oncol. 2009 Jul;20(7):1249-56. doi: 10.1093/annonc/mdn774. Epub 2009 Mar 10.
PubMed 19276396Yang JJ, Zhou Q, Liao RQ, Huang YS, Xu CR, Wang Z, Wang BC, Chen HJ, Wu YL. Nedaplatin/Gemcitabine Versus Carboplatin/Gemcitabine in Treatment of Advanced Non-small Cell Lung Cancer: A Randomized Clinical Trial. Chin J Cancer Res. 2012 Jun;24(2):97-102. doi: 10.1007/s11670-012-0097-8.
PubMed 23359648Teramoto K, Asada Y, Ozaki Y, Suzumura Y, Nakano Y, Sawai S, Tezuka N, Inoue S, Fujino S. A phase II study of docetaxel plus nedaplatin in patients with metastatic non-small-cell lung cancer. Cancer Chemother Pharmacol. 2012 Oct;70(4):531-7. doi: 10.1007/s00280-012-1941-8. Epub 2012 Aug 5.
PubMed 22864949Naito Y, Kubota K, Ohmatsu H, Goto K, Niho S, Yoh K, Ohe Y. Phase II study of nedaplatin and docetaxel in patients with advanced squamous cell carcinoma of the lung. Ann Oncol. 2011 Nov;22(11):2471-2475. doi: 10.1093/annonc/mdq781. Epub 2011 Mar 4.
PubMed 21378204Oshita F, Yamada K, Kato Y, Ikehara M, Noda K, Tanaka G, Nomura I, Suzuki R, Saito H. Phase I/II study of escalating doses of nedaplatin in combination with irinotecan for advanced non-small-cell lung cancer. Cancer Chemother Pharmacol. 2003 Jul;52(1):73-8. doi: 10.1007/s00280-003-0615-y. Epub 2003 May 16.
PubMed 12750839Shirai T, Hirose T, Noda M, Ando K, Ishida H, Hosaka T, Ozawa T, Okuda K, Ohnishi T, Ohmori T, Horichi N, Adachi M. Phase II study of the combination of gemcitabine and nedaplatin for advanced non-small-cell lung cancer. Lung Cancer. 2006 May;52(2):181-7. doi: 10.1016/j.lungcan.2006.01.004. Epub 2006 Mar 24.
PubMed 16563558Sznol M. Blockade of the B7-H1/PD-1 pathway as a basis for combination anticancer therapy. Cancer J. 2014 Jul-Aug;20(4):290-5. doi: 10.1097/PPO.0000000000000056.
PubMed 25098290Konishi J, Yamazaki K, Azuma M, Kinoshita I, Dosaka-Akita H, Nishimura M. B7-H1 expression on non-small cell lung cancer cells and its relationship with tumor-infiltrating lymphocytes and their PD-1 expression. Clin Cancer Res. 2004 Aug 1;10(15):5094-100. doi: 10.1158/1078-0432.CCR-04-0428.
PubMed 15297412Patel SP, Kurzrock R. PD-L1 Expression as a Predictive Biomarker in Cancer Immunotherapy. Mol Cancer Ther. 2015 Apr;14(4):847-56. doi: 10.1158/1535-7163.MCT-14-0983. Epub 2015 Feb 18.
PubMed 25695955
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nedaplatin/Docetaxel Versus Cisplatin/Docetaxel in Treatment of Advanced/Relapsed Squamous Cell Lung Cancer :A Randomized, Open, Parallel, Multicentre, Phase Ⅲ Study
- ClinicalTrials.gov ID
- NCT02643407
- Acronym / sponsor ID
- CTONG1501
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- squamous cell carcinoma, nedaplatin, cisplatin, docetaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 31 Dec 2015 (estimated)
- 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.
To compare the efficacy and safety of docetaxel plus nedaplatin with docetaxel plus cisplatin in managment of advanced/relapsed squamous cell lung cancer.
Detailed description
This study is prospective to evaluate whether the efficacy and safety of docetaxel plus nedaplatin is non-inferior to docetaxel plus cisplatin in managment of advanced/relapsed squamous cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel plus Nedaplatin | Experimental | Drug: Docetaxel, Drug: Nedaplatindocetaxel 60mg/m2 and nedaplatin 80mg/m2, d1 every 3 weeks |
| Docetaxel plus Cisplatin | Active comparator | Drug: Docetaxel, Drug: Cisplatindocetaxel 60mg/m2 and cisplatin 75mg/m2, d1 every 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients were required to be between 18 to 75 years, with histologically or cytologically proven squamous cell carcinoma of the lung, stage ⅢB (unfit for definitive radiotherapy), stage Ⅳ or relapsing;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of zero or one;
- life expectancy > 3 months;
- No previous history of malignancy (except adequately treated carcinoma-in-situ of the cervix or basal cell carcinoma of the skin or superficial bladder cancer [Ta, Tis \& T1]); previously untreated with chemotherapy (eg. gemcitabine, platinum, paclitaxel); no previously systemic therapy on locally advanced and metastatic disease; patients were eligible for participation in the study if they had recurrence or metastasis and became locally advanced or metastatic lung cancer after 12 months treatment with gemcitabine, platinum or paclitaxel regimen in adjuvant or neoadjuvant chemotherapy;
- Adequate organ function was required, as evidenced by absolute neutrophil count ≥ 1.5 x 109 /L, platelet count ≥ 100 x109/L, hemoglobin ≥ 90 g/L (9 g/dL);
Key exclusion criteria (15 listed)
- EGFR positive or ALK positive (patients, the status of EGFR and ALK were unknown due to the detection, were included);
- Participation in any clinical research in 4 weeks before the first dosage, except non interventional epidemiological investigation;
- Patients with the complications in high risk;
- Primary brain tumors or central nervous system (CNS) metastatic carcinoma. The patients who are suspected the CNS metastatic carcinoma should be scanned in 28 days before entering the group. Other malignant disease five years ago (except cone-biopsied carcinoma-in-situ of the cervix or adequately treated basal or squamous cell carcinoma of the skin)
- Third-space fluid collection that has the clinical significance, such as ascites or pleural effusion, cannot control through the drainage or other method;
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 |
|---|---|---|
| Docetaxel60mg/m2 | Drug | Docetaxel plus Cisplatin, Docetaxel plus Nedaplatin |
| Nedaplatin80mg/m2 | Drug | Docetaxel plus Nedaplatin |
| Cisplatin75mg/m2 | Drug | Docetaxel plus Cisplatin |
Primary outcome
PFS
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Background: PubMed 23401433Li T, Kung HJ, Mack PC, Gandara DR. Genotyping and genomic profiling of non-small-cell lung cancer: implications for current and future therapies. J Clin Oncol. 2013 Mar 10;31(8):1039-49. doi: 10.1200/JCO.2012.45.3753. Epub 2013 Feb 11.
- Background: PubMed 17888036Mitsudomi T, Yatabe Y. Mutations of the epidermal growth factor receptor gene and related genes as determinants of epidermal growth factor receptor tyrosine kinase inhibitors sensitivity in lung cancer. Cancer Sci. 2007 Dec;98(12):1817-24. doi: 10.1111/j.1349-7006.2007.00607.x. Epub 2007 Sep 20.
- Background: PubMed 17625570Soda M, Choi YL, Enomoto M, Takada S, Yamashita Y, Ishikawa S, Fujiwara S, Watanabe H, Kurashina K, Hatanaka H, Bando M, Ohno S, Ishikawa Y, Aburatani H, Niki T, Sohara Y, Sugiyama Y, Mano H. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature. 2007 Aug 2;448(7153):561-6. doi: 10.1038/nature05945. Epub 2007 Jul 11.
- Background: PubMed 11784875Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.
- Background: PubMed 23611404Hoang T, Dahlberg SE, Schiller JH, Johnson DH. Does histology predict survival of advanced non-small cell lung cancer patients treated with platin-based chemotherapy? An analysis of the Eastern Cooperative Oncology Group Study E1594. Lung Cancer. 2013 Jul;81(1):47-52. doi: 10.1016/j.lungcan.2013.03.018. Epub 2013 Apr 21.
- Background: PubMed 12837811Fossella F, Pereira JR, von Pawel J, Pluzanska A, Gorbounova V, Kaukel E, Mattson KV, Ramlau R, Szczesna A, Fidias P, Millward M, Belani CP. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol. 2003 Aug 15;21(16):3016-24. doi: 10.1200/JCO.2003.12.046. Epub 2003 Jul 1.
- Background: PubMed 19276396Tan EH, Rolski J, Grodzki T, Schneider CP, Gatzemeier U, Zatloukal P, Aitini E, Carteni G, Riska H, Tsai YH, Abratt R. Global Lung Oncology Branch trial 3 (GLOB3): final results of a randomised multinational phase III study alternating oral and i.v. vinorelbine plus cisplatin versus docetaxel plus cisplatin as first-line treatment of advanced non-small-cell lung cancer. Ann Oncol. 2009 Jul;20(7):1249-56. doi: 10.1093/annonc/mdn774. Epub 2009 Mar 10.
- Background: PubMed 23359648Yang JJ, Zhou Q, Liao RQ, Huang YS, Xu CR, Wang Z, Wang BC, Chen HJ, Wu YL. Nedaplatin/Gemcitabine Versus Carboplatin/Gemcitabine in Treatment of Advanced Non-small Cell Lung Cancer: A Randomized Clinical Trial. Chin J Cancer Res. 2012 Jun;24(2):97-102. doi: 10.1007/s11670-012-0097-8.
- Background: PubMed 22864949Teramoto K, Asada Y, Ozaki Y, Suzumura Y, Nakano Y, Sawai S, Tezuka N, Inoue S, Fujino S. A phase II study of docetaxel plus nedaplatin in patients with metastatic non-small-cell lung cancer. Cancer Chemother Pharmacol. 2012 Oct;70(4):531-7. doi: 10.1007/s00280-012-1941-8. Epub 2012 Aug 5.
- Background: PubMed 21378204Naito Y, Kubota K, Ohmatsu H, Goto K, Niho S, Yoh K, Ohe Y. Phase II study of nedaplatin and docetaxel in patients with advanced squamous cell carcinoma of the lung. Ann Oncol. 2011 Nov;22(11):2471-2475. doi: 10.1093/annonc/mdq781. Epub 2011 Mar 4.
- Background: PubMed 12750839Oshita F, Yamada K, Kato Y, Ikehara M, Noda K, Tanaka G, Nomura I, Suzuki R, Saito H. Phase I/II study of escalating doses of nedaplatin in combination with irinotecan for advanced non-small-cell lung cancer. Cancer Chemother Pharmacol. 2003 Jul;52(1):73-8. doi: 10.1007/s00280-003-0615-y. Epub 2003 May 16.
- Background: PubMed 16563558Shirai T, Hirose T, Noda M, Ando K, Ishida H, Hosaka T, Ozawa T, Okuda K, Ohnishi T, Ohmori T, Horichi N, Adachi M. Phase II study of the combination of gemcitabine and nedaplatin for advanced non-small-cell lung cancer. Lung Cancer. 2006 May;52(2):181-7. doi: 10.1016/j.lungcan.2006.01.004. Epub 2006 Mar 24.
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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.
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel, Nedaplatin and Cisplatin in people with Non-Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials 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 11 inclusion and 15 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 31 Dec 2015. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02643407, which also lists 24 linked publications.
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 31 Dec 2015.