Non-small Cell Lung CancerPhase 4NCT02480634
Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer
A Phase 4 study testing Zoledronic acid and Radiotherapy in people with Non-small Cell Lung Cancer and Bone Metastasis, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Trial summary
This study will give comparison of the bone pain remission and the adverse reaction of Zoledronic acid combine with High dose fractionation radiotherapy(30Gy/10f) and Zoledronic acid combine with low dose fractionation radiotherapy(15Gy/5f) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Bone Metastasis
- What is being tested?
- Zoledronic acid and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Dec 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathology or cytology was diagnosed with non-small cell lung cancer, and bone metastases was confirmed by CT or MRI , and the patients have to need intervention treatment.
- VAS score>2 points.
- No paraplegia,
- No pathological fractures of bone related events which require surgical intervention,
- No major organ dysfunction,laboratory indexes meet the following requirements: Haemamoeba >4.0 x 10^9/L, Neutrophile granulocyte > 2 x 10^9/L, the platelet count>100 x 10^9/L, hemoglobin>100 g/L; Liver result: the serum bilirubin is lower than normal ceiling; ALT and AST is lower than the maximum normal 1.5 times; Cr<265 umol/l or 3.0 mg/dl, creatinine clearance>60 ml/min.
Who cannot join
- The patients who have allergy of Bisphosphonates and zoledronate.
- The patients who receive Molecular targeted therapy and chemotherapy within one month，The patients who receive Calcitonin and Aminoglycoside therapy in one week.
- The patients who receive Pamidronic Acid in 28 days，The patients original sites receive radiotherapy before.
- The patients who have history of thyroid surgery，receive tooth extraction in 2 weeks，and have been suffered from Bone Fracture and paraplegia.
- The patients who have Serious internal medicine diseases and acute infection.
- The patients With a history of psychiatric
- Pregnancy or breast-feeding women, men have fertility requirements
- Patients within clinical trials or not more than 30 days
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer: A Non-inferiority, Randomized, Open, Parallel and Controlled Prospective Clinical Study
This study will give comparison of the bone pain remission and the adverse reaction of Zoledronic acid combine with High dose fractionation radiotherapy(30Gy/10f) and Zoledronic acid combine with low dose fractionation radiotherapy(15Gy/5f) . The purpose of this trial is to prove whether Zoledronic acid combine radiotherapy can reduce radiotherapy dose in treatment of non-small cell lung cancer bone metastasis'pain relief or not.
Read the detailed description
Further study details as provided by oncology center of Daping hospital
- Conditions
- Non-small Cell Lung Cancer, Bone Metastasis
- Being tested
- Zoledronic acid, Radiotherapy
- Keywords
- zoledronic acid, radiotherapy
- 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.
Zoledronic acidDrug
Also called Zometa
Comparison the curative effect of the high does radiotherapy and low does therapy after use the Zoledronic acid
RadiotherapyRadiation
High dose：30Gy/10f Low dose：15Gy/5f
| Study group | Role | What they receive |
|---|---|---|
| High dose group | Active comparator | Zoledronic acid 4 mg + 0.9% sodium chloride injection 100 ml intravenous drip more than 15 min, 28 days for a transfusion cycle , a total of six cycle，Radiotherapy dose: 30Gy/10f Receives: Drug: Zoledronic acid; Radiation: Radiotherapy |
| Low dose group | Experimental | Zoledronic acid 4 mg + 0.9% sodium chloride injection 100 ml intravenous drip more than 15 min, 28 days for a transfusion cycle, a total of six cycle，Radiotherapy dose: 15Gy/5f Receives: Drug: Zoledronic acid; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants reach objective response
Objective response is defined as the patients bone pain relief reach PR(Partial remission) or CR(Complete remission).and Objective response rate is defined as Objective response patients'percentage in total patients.
Time evaluation points 1 month is the time after radiotherapy.
Measured: Up to 1 month
Secondary outcomes (6)
Percentage of Participants occur bone pain recurrence at 1 to 12 month after radiotherapy.
Bone pain Recurrence is defined as the time of the original parts again pain and the VAS is more than 4 points.
Measured: every months up to the 12th month after treatment
Pain relief time in/after treatment
Pain relief time is defined as the time of the VAS(Visual analogue scale) score reduce 2 points or the analgesic reduce 25% after the radiotherapy Time evaluation points :when patients in treatment ,we shall evaluate pain scores everyday ; when patients after treatment,we shall evluate pain scores every month.
Measured: everyday in treatment and every months up to 12 monthes
Incidence of SRE(Skeletal-related events) again in Participants
Incidence of SRE again is defined as the Participants occur SRE events after treatment.
Time evaluation points :When patients were after treat,we shall evaluate whether occur SRE again every month.
Measured: every monthes up to the 12th month after treatment
Security of the therapy
Time evaluation points :when patients were in treatment ,we shall evaluate the toxicity everyday ; when patients were after treatment,we shall evluate toxicity every month.
Method：Using RTOG acute radiation injury grading assessment and RTOG / EORTC late radiation injury grading for radiotherapy toxicity，CTCAE V3.0 for Adverse drug reactions.
Measured: everyday in treatment and every months up to the 12th month after treatment
Percentage of the osteogenic and the osteolytic sites reach objective response
Measured: every months up to the 12th month
Kaplan-Meier Estimates for Overall Survival after bone metastases
Measured: every months up to the 12th month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2019 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Ge, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Ge Wang, Doctor, Study director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480634
- Sponsor's protocol ID
- DPRA-1023-SK
- Status last verified
- Jan 2019
- First submitted
- 17 Mar 2015
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akbar RA, Gosh SK, Khalil S, ul Haq SM. Zoledronic acid in metastatic bone disease: an audit based discussion. J Ayub Med Coll Abbottabad. 2010 Jul-Sep;22(3):5-7.
PubMed 22338405Wu JS, Wong R, Johnston M, Bezjak A, Whelan T; Cancer Care Ontario Practice Guidelines Initiative Supportive Care Group. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):594-605. doi: 10.1016/s0360-3016(02)04147-0.
PubMed 12573746Chow E, Wu JS, Hoskin P, Coia LR, Bentzen SM, Blitzer PH. International consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Radiother Oncol. 2002 Sep;64(3):275-80. doi: 10.1016/s0167-8140(02)00170-6.
PubMed 12242115Chow E, Hoskin P, Mitera G, Zeng L, Lutz S, Roos D, Hahn C, van der Linden Y, Hartsell W, Kumar E; International Bone Metastases Consensus Working Party. Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1730-7. doi: 10.1016/j.ijrobp.2011.02.008. Epub 2011 Apr 12.
PubMed 21489705Dennis K, Makhani L, Zeng L, Lam H, Chow E. Single fraction conventional external beam radiation therapy for bone metastases: a systematic review of randomised controlled trials. Radiother Oncol. 2013 Jan;106(1):5-14. doi: 10.1016/j.radonc.2012.12.009. Epub 2013 Jan 13.
PubMed 23321492Luo KW, Ko CH, Yue GG, Lee MY, Siu WS, Lee JK, Shum WT, Fung KP, Leung PC, Li G, Evdokiou A, Lau CB. Anti-tumor and anti-osteolysis effects of the metronomic use of zoledronic acid in primary and metastatic breast cancer mouse models. Cancer Lett. 2013 Oct 1;339(1):42-8. doi: 10.1016/j.canlet.2013.07.024. Epub 2013 Jul 26.
PubMed 23896464Denham JW, Wilcox C, Joseph D, Spry NA, Lamb DS, Tai KH, Matthews J, Atkinson C, Turner S, Christie D, Gogna NK, Kenny L, Duchesne G, Delahunt B, McElduff P. Quality of life in men with locally advanced prostate cancer treated with leuprorelin and radiotherapy with or without zoledronic acid (TROG 03.04 RADAR): secondary endpoints from a randomised phase 3 factorial trial. Lancet Oncol. 2012 Dec;13(12):1260-70. doi: 10.1016/S1470-2045(12)70423-0. Epub 2012 Nov 12.
PubMed 23151431Denham JW, Joseph D, Lamb DS, Spry NA, Duchesne G, Matthews J, Atkinson C, Tai KH, Christie D, Kenny L, Turner S, Gogna NK, Diamond T, Delahunt B, Oldmeadow C, Attia J, Steigler A. Short-term androgen suppression and radiotherapy versus intermediate-term androgen suppression and radiotherapy, with or without zoledronic acid, in men with locally advanced prostate cancer (TROG 03.04 RADAR): an open-label, randomised, phase 3 factorial trial. Lancet Oncol. 2014 Sep;15(10):1076-89. doi: 10.1016/S1470-2045(14)70328-6. Epub 2014 Aug 14.
PubMed 25130995Deberne M, Ropert S, Billemont B, Daniel C, Chapron J, Goldwasser F. Inaugural bone metastases in non-small cell lung cancer: a specific prognostic entity? BMC Cancer. 2014 Jun 10;14:416. doi: 10.1186/1471-2407-14-416.
PubMed 24913188Peng H, Ma M, Han B. [Survival analysis of 1,742 patients with stage IV non-small cell lung cancer]. Zhongguo Fei Ai Za Zhi. 2011 Apr;14(4):362-6. doi: 10.3779/j.issn.1009-3419.2011.04.11. Chinese.
PubMed 21496437Bae HM, Lee SH, Kim TM, Kim DW, Yang SC, Wu HG, Kim YW, Heo DS. Prognostic factors for non-small cell lung cancer with bone metastasis at the time of diagnosis. Lung Cancer. 2012 Sep;77(3):572-7. doi: 10.1016/j.lungcan.2012.05.094. Epub 2012 Jun 4.
PubMed 22672969Nakamura N, Shikama N, Wada H, Harada H, Nozaki M, Nagakura H, Tago M, Oguchi M, Uchida N; Japanese Radiation Oncology Study Group Working Subgroup of Palliative Radiotherapy. Patterns of practice in palliative radiotherapy for painful bone metastases: a survey in Japan. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):e117-20. doi: 10.1016/j.ijrobp.2011.11.075. Epub 2012 Feb 28.
PubMed 22381902Brown JE, Cook RJ, Major P, Lipton A, Saad F, Smith M, Lee KA, Zheng M, Hei YJ, Coleman RE. Bone turnover markers as predictors of skeletal complications in prostate cancer, lung cancer, and other solid tumors. J Natl Cancer Inst. 2005 Jan 5;97(1):59-69. doi: 10.1093/jnci/dji002.
PubMed 15632381Sun JM, Ahn JS, Lee S, Kim JA, Lee J, Park YH, Park HC, Ahn MJ, Ahn YC, Park K. Predictors of skeletal-related events in non-small cell lung cancer patients with bone metastases. Lung Cancer. 2011 Jan;71(1):89-93. doi: 10.1016/j.lungcan.2010.04.003. Epub 2010 Jul 3.
PubMed 20598769Zhang L, Hou X, Lu S, Rao H, Hou J, Luo R, Huang H, Zhao H, Jian H, Chen Z, Liao M, Wang X. Predictive significance of bone sialoprotein and osteopontin for bone metastases in resected Chinese non-small-cell lung cancer patients: a large cohort retrospective study. Lung Cancer. 2010 Jan;67(1):114-9. doi: 10.1016/j.lungcan.2009.03.017.
PubMed 19376608
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer: A Non-inferiority, Randomized, Open, Parallel and Controlled Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT02480634
- Acronym / sponsor ID
- DPRA-1023-SK
- Conditions
- Non-small Cell Lung Cancer, Bone Metastasis
- Keywords
- zoledronic acid, radiotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 Jun 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.
This study will give comparison of the bone pain remission and the adverse reaction of Zoledronic acid combine with High dose fractionation radiotherapy(30Gy/10f) and Zoledronic acid combine with low dose fractionation radiotherapy(15Gy/5f) . The purpose of this trial is to prove whether Zoledronic acid combine radiotherapy can reduce radiotherapy dose in treatment of non-small cell lung cancer bone metastasis'pain relief or not.
Detailed description
Further study details as provided by oncology center of Daping hospital
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose group | Active comparator | Drug: Zoledronic acid, Radiation: RadiotherapyZoledronic acid 4 mg + 0.9% sodium chloride injection 100 ml intravenous drip more than 15 min, 28 days for a transfusion cycle , a total of six cycle，Radiotherapy dose: 30Gy/10f |
| Low dose group | Experimental | Drug: Zoledronic acid, Radiation: RadiotherapyZoledronic acid 4 mg + 0.9% sodium chloride injection 100 ml intravenous drip more than 15 min, 28 days for a transfusion cycle, a total of six cycle，Radiotherapy dose: 15Gy/5f |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathology or cytology was diagnosed with non-small cell lung cancer, and bone metastases was confirmed by CT or MRI , and the patients have to need intervention treatment.
- VAS score>2 points.
- No paraplegia,
- No pathological fractures of bone related events which require surgical intervention,
- No major organ dysfunction,laboratory indexes meet the following requirements: Haemamoeba >4.0 x 10^9/L, Neutrophile granulocyte > 2 x 10^9/L, the platelet count>100 x 10^9/L, hemoglobin>100 g/L; Liver result: the serum bilirubin is lower than normal ceiling; ALT and AST is lower than the maximum normal 1.5 times; Cr<265 umol/l or 3.0 mg/dl, creatinine clearance>60 ml/min.
Key exclusion criteria (8 listed)
- The patients who have allergy of Bisphosphonates and zoledronate.
- The patients who receive Molecular targeted therapy and chemotherapy within one month，The patients who receive Calcitonin and Aminoglycoside therapy in one week.
- The patients who receive Pamidronic Acid in 28 days，The patients original sites receive radiotherapy before.
- The patients who have history of thyroid surgery，receive tooth extraction in 2 weeks，and have been suffered from Bone Fracture and paraplegia.
- The patients who have Serious internal medicine diseases and acute infection.
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 |
|---|---|---|
| Zoledronic acidAlso: ZometaComparison the curative effect of the high does radiotherapy and low does therapy after use the Zoledronic acid | Drug | High dose group, Low dose group |
| RadiotherapyHigh dose：30Gy/10f Low dose：15Gy/5f | Radiation | High dose group, Low dose group |
Primary outcome
Percentage of Participants reach objective response
Time frame: Up to 1 month
Objective response is defined as the patients bone pain relief reach PR(Partial remission) or CR(Complete remission).and Objective response rate is defined as Objective response patients'percentage in total patients. Time evaluation points 1 month is the time after radiotherapy.
6 secondary outcomes
Percentage of Participants occur bone pain recurrence at 1 to 12 month after radiotherapy.
Time frame: every months up to the 12th month after treatment
Pain relief time in/after treatment
Time frame: everyday in treatment and every months up to 12 monthes
Incidence of SRE(Skeletal-related events) again in Participants
Time frame: every monthes up to the 12th month after treatment
Security of the therapy
Time frame: everyday in treatment and every months up to the 12th month after treatment
Percentage of the osteogenic and the osteolytic sites reach objective response
Time frame: every months up to the 12th month
Kaplan-Meier Estimates for Overall Survival after bone metastases
Time frame: every months up to the 12th month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Background: PubMed 22338405Akbar RA, Gosh SK, Khalil S, ul Haq SM. Zoledronic acid in metastatic bone disease: an audit based discussion. J Ayub Med Coll Abbottabad. 2010 Jul-Sep;22(3):5-7.
- Background: PubMed 12573746Wu JS, Wong R, Johnston M, Bezjak A, Whelan T; Cancer Care Ontario Practice Guidelines Initiative Supportive Care Group. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):594-605. doi: 10.1016/s0360-3016(02)04147-0.
- Background: PubMed 12242115Chow E, Wu JS, Hoskin P, Coia LR, Bentzen SM, Blitzer PH. International consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Radiother Oncol. 2002 Sep;64(3):275-80. doi: 10.1016/s0167-8140(02)00170-6.
- Background: PubMed 21489705Chow E, Hoskin P, Mitera G, Zeng L, Lutz S, Roos D, Hahn C, van der Linden Y, Hartsell W, Kumar E; International Bone Metastases Consensus Working Party. Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1730-7. doi: 10.1016/j.ijrobp.2011.02.008. Epub 2011 Apr 12.
- Background: PubMed 23321492Dennis K, Makhani L, Zeng L, Lam H, Chow E. Single fraction conventional external beam radiation therapy for bone metastases: a systematic review of randomised controlled trials. Radiother Oncol. 2013 Jan;106(1):5-14. doi: 10.1016/j.radonc.2012.12.009. Epub 2013 Jan 13.
- Background: PubMed 23896464Luo KW, Ko CH, Yue GG, Lee MY, Siu WS, Lee JK, Shum WT, Fung KP, Leung PC, Li G, Evdokiou A, Lau CB. Anti-tumor and anti-osteolysis effects of the metronomic use of zoledronic acid in primary and metastatic breast cancer mouse models. Cancer Lett. 2013 Oct 1;339(1):42-8. doi: 10.1016/j.canlet.2013.07.024. Epub 2013 Jul 26.
- Background: PubMed 23151431Denham JW, Wilcox C, Joseph D, Spry NA, Lamb DS, Tai KH, Matthews J, Atkinson C, Turner S, Christie D, Gogna NK, Kenny L, Duchesne G, Delahunt B, McElduff P. Quality of life in men with locally advanced prostate cancer treated with leuprorelin and radiotherapy with or without zoledronic acid (TROG 03.04 RADAR): secondary endpoints from a randomised phase 3 factorial trial. Lancet Oncol. 2012 Dec;13(12):1260-70. doi: 10.1016/S1470-2045(12)70423-0. Epub 2012 Nov 12.
- Background: PubMed 25130995Denham JW, Joseph D, Lamb DS, Spry NA, Duchesne G, Matthews J, Atkinson C, Tai KH, Christie D, Kenny L, Turner S, Gogna NK, Diamond T, Delahunt B, Oldmeadow C, Attia J, Steigler A. Short-term androgen suppression and radiotherapy versus intermediate-term androgen suppression and radiotherapy, with or without zoledronic acid, in men with locally advanced prostate cancer (TROG 03.04 RADAR): an open-label, randomised, phase 3 factorial trial. Lancet Oncol. 2014 Sep;15(10):1076-89. doi: 10.1016/S1470-2045(14)70328-6. Epub 2014 Aug 14.
- Background: PubMed 24913188Deberne M, Ropert S, Billemont B, Daniel C, Chapron J, Goldwasser F. Inaugural bone metastases in non-small cell lung cancer: a specific prognostic entity? BMC Cancer. 2014 Jun 10;14:416. doi: 10.1186/1471-2407-14-416.
- Background: PubMed 21496437Peng H, Ma M, Han B. [Survival analysis of 1,742 patients with stage IV non-small cell lung cancer]. Zhongguo Fei Ai Za Zhi. 2011 Apr;14(4):362-6. doi: 10.3779/j.issn.1009-3419.2011.04.11. Chinese.
- Background: PubMed 22672969Bae HM, Lee SH, Kim TM, Kim DW, Yang SC, Wu HG, Kim YW, Heo DS. Prognostic factors for non-small cell lung cancer with bone metastasis at the time of diagnosis. Lung Cancer. 2012 Sep;77(3):572-7. doi: 10.1016/j.lungcan.2012.05.094. Epub 2012 Jun 4.
- Background: PubMed 22381902Nakamura N, Shikama N, Wada H, Harada H, Nozaki M, Nagakura H, Tago M, Oguchi M, Uchida N; Japanese Radiation Oncology Study Group Working Subgroup of Palliative Radiotherapy. Patterns of practice in palliative radiotherapy for painful bone metastases: a survey in Japan. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):e117-20. doi: 10.1016/j.ijrobp.2011.11.075. Epub 2012 Feb 28.
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Ge Wang, Doctor study director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoledronic acid and Radiotherapy in people with Non-small Cell Lung Cancer and Bone Metastasis, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
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 5 inclusion and 8 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jian Li, Graduate (15310926602, lmno051049@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants reach objective response (time frame: Up to 1 month). 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 NCT02480634, which also lists 31 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 16 Jan 2019.