AzTrials
AzTrials

Non-small-cell Lung CancerPhase 2NCT02577341

Nimotuzumab Combined With Chemoradiotherapy for Unresectable Locally Advanced Squamous Cell Lung Cancer

A Phase 2 study testing Nimotuzumab, docetaxel and cisplatin and daily RT to the chest in people with Non-small-cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced 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?
Nimotuzumab, docetaxel and cisplatin and daily RT to the chest
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteChina
Study dates
Aug 2015to Oct 2020
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

  • histologically confirmed squamous cell lung cancer
  • patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • unresectable phase IIIA(N2) and IIIB lung cancer confirmed by CT or MRI
  • ECOG performance status 0-1
  • Previously treated with chemotherapy or treatment-naive
  • no previous chest radiotherapy, immunotherapy or biotherapy.
Show all 12Show fewer
  • hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
  • serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
  • bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
  • FEV1 >0.8 L
  • CB6 within normal limits
  • patients and their family signed the informed consents

Who cannot join

  • adenosquamous carcinoma
  • previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
  • contraindication for chemotherapy
  • women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
  • women who has the probability of pregnancy without contraception
  • tendency of hemorrhage
Show all 11Show fewer
  • in other clinical trials within 30 days
  • addicted in drugs or alcohol, AIDS patients
  • uncontrollable seizure or psychotic patients without self-control ability
  • severe allergy or idiosyncrasy
  • not suitable for this study judged by researchers

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: A Prospective Randomized Phase Ⅱ Study of Nimotuzumab Combined With Chemoradiotherapy for Unresectable, Locally Advanced Squamous Cell Lung Cancer

This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.

Read the detailed description

This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab combined with chemoradiotherapy for unresectable,locally advanced squamous cell lung cancer.

All patients were planned to receive radical dose of chest radiation and concurrent chemotherapy of weekly docetaxel and cisplatin, each of 1 day's duration.

Nimotuzumab group was treated with weekly nimotuzumab (200mg, IV) combined with chemoradiotherapy, while control group was treated with chemoradiotherapy.

Being tested
Nimotuzumab, docetaxel and cisplatin, daily RT to the chest
Keywords
Nimotuzumab, Chemoradiotherapy,Squamous Cell Lung Cancer
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.

  • NimotuzumabDrug

    Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy.

  • docetaxel and cisplatinDrug

    Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy

  • daily RT to the chestRadiation

    Patients received daily RT to the chest

Study groups in NCT02577341
Study groupRoleWhat they receive
NimotuzumabExperimentalDaily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.
Receives: Drug: Nimotuzumab; Drug: docetaxel and cisplatin; Radiation: daily RT to the chest
ControlActive comparatorDaily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin.
Receives: Drug: docetaxel and cisplatin; Radiation: daily RT to the chest

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: 3 years

Secondary outcomes (5)

  1. Objective Response Rate

    Measured: 3 years

  2. progression-free survival

    Measured: 3 years

  3. rate of grade 3-4 radiation esophagitis

    rate of grade 3-4 radiation esophagitis as assessed by CTCAE v4.0

    Measured: 1 years

  4. rate of grade 3-4 radiation pneumonitis

    rate of grade 3-4 radiation pneumonitis as assessed by CTCAE v4.0

    Measured: 1 year

  5. Failure patterns

    rates of local-regional recurrence, distant metastasis and brain metastasis

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJun 2020
  4. Study completionOct 2020

Resources

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
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02577341
Sponsor's protocol ID
2014-FXY-061
Status last verified
Feb 2021
First submitted
12 Oct 2015
Last updated
11 Feb 2021
Results posted
No
Data monitoring committee
No

Publications

  • Steel GG, Hill RP, Peckham MJ. Combined radiotherapy--chemotherapy of Lewis lung carcinoma. Int J Radiat Oncol Biol Phys. 1978 Jan-Feb;4(1-2):49-52. doi: 10.1016/0360-3016(78)90114-1. No abstract available.

    PubMed 632147

  • Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ. 1995 Oct 7;311(7010):899-909.

    PubMed 7580546

  • Marino P, Preatoni A, Cantoni A. Randomized trials of radiotherapy alone versus combined chemotherapy and radiotherapy in stages IIIa and IIIb nonsmall cell lung cancer. A meta-analysis. Cancer. 1995 Aug 15;76(4):593-601. doi: 10.1002/1097-0142(19950815)76:43.0.co;2-n.

    PubMed 8625152

  • Pritchard RS, Anthony SP. Chemotherapy plus radiotherapy compared with radiotherapy alone in the treatment of locally advanced, unresectable, non-small-cell lung cancer. A meta-analysis. Ann Intern Med. 1996 Nov 1;125(9):723-9. doi: 10.7326/0003-4819-125-9-199611010-00003.

    PubMed 8929005

  • Kubota K, Furuse K, Kawahara M, Kodama N, Yamamoto M, Ogawara M, Negoro S, Masuda N, Takada M, Matsui K, et al. Role of radiotherapy in combined modality treatment of locally advanced non-small-cell lung cancer. J Clin Oncol. 1994 Aug;12(8):1547-52. doi: 10.1200/JCO.1994.12.8.1547.

    PubMed 8040666

  • Clinical practice guidelines for the treatment of unresectable non-small-cell lung cancer. Adopted on May 16, 1997 by the American Society of Clinical Oncology. J Clin Oncol. 1997 Aug;15(8):2996-3018. doi: 10.1200/JCO.1997.15.8.2996.

    PubMed 9256144

  • Stanley KE. Prognostic factors for survival in patients with inoperable lung cancer. J Natl Cancer Inst. 1980 Jul;65(1):25-32.

    PubMed 6930515

  • Mornex F, Houtte PV, Scalliet P, Loubeyre P. [Radiotherapy for non-small-cell bronchial cancers: definitions of volumes, patient selection. Recommendations of the International Association for the Study of Lung Cancer (IASLC)]. Cancer Radiother. 1998 Sep-Oct;2(5):579-89. doi: 10.1016/s1278-3218(98)80091-7. French.

    PubMed 9868404

  • Paesmans M, Sculier JP, Libert P, Bureau G, Dabouis G, Thiriaux J, Michel J, Van Cutsem O, Sergysels R, Mommen P, et al. Prognostic factors for survival in advanced non-small-cell lung cancer: univariate and multivariate analyses including recursive partitioning and amalgamation algorithms in 1,052 patients. The European Lung Cancer Working Party. J Clin Oncol. 1995 May;13(5):1221-30. doi: 10.1200/JCO.1995.13.5.1221.

    PubMed 7738625

  • Scott C, Sause WT, Byhardt R, Marcial V, Pajak TF, Herskovic A, Cox JD. Recursive partitioning analysis of 1592 patients on four Radiation Therapy Oncology Group studies in inoperable non-small cell lung cancer. Lung Cancer. 1997 Jun;17 Suppl 1:S59-74. doi: 10.1016/s0169-5002(97)00640-5.

    PubMed 9213303

  • Curran WJ, Scott C, Langer C, et al. Phase III comoarision of sequential vs concurrent chemoradiation therapy for patients with unresectable stage III non-small cell lung cancer: initial report of RTOG 9410. Proc Am Soc Clin Oncol, 2000, 19: 484a.

  • Furuse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692.

    PubMed 10561343

  • Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.

    PubMed 20351327

  • Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR; American Society of Clinical Oncology. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol. 2004 Jan 15;22(2):330-53. doi: 10.1200/JCO.2004.09.053. Epub 2003 Dec 22. No abstract available.

    PubMed 14691125

  • Ardizzoni A, Tiseo M, Boni L et al. CISCA (cis-platin vs. carboplatin) meta-analysis: an individual patient data meta-analysis comparing cisplatin versus carboplatin-based chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC) [Abstract 7011]. Proc AmSoc Clin Oncol 2006;24:366S.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nimotuzumab, docetaxel and cisplatin and daily RT to the chest in people with Non-small-cell Lung Cancer, run by Sun Yat-sen University 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 12 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 11 Feb 2021. 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?

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?

overall survival (time frame: 3 years). 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 NCT02577341, which also lists 47 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 11 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in