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AdenocarcinomaPhase 2APICALNCT02498860

Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung

A Phase 2 study testing Pemebit and Cisplatin in people with Adenocarcinoma and Lung Neoplasm, run by Chonnam National University Hospital at 7 sites in South Korea.

Completed

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

Official record
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Trial summary

Two-Year Disease Free Survival Rate of Stage IB~IIIA adenocarcinoma after Adjuvant Chemotherapy with Pemetrexed and Cisplatin will be assessed. A total of 106 patients will be recruited for 12 months, and followed for two years, thus the duration of study will be 36 months. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Adenocarcinoma, Lung Neoplasm
What is being tested?
Pemebit and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
7 sitesSouth Korea
Study dates
1 Sep 2015to 31 Jul 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adenocarcinoma of Lung
  • Postoperative pathologic stage IB~IIIA
  • Complete surgical resection (R0 resection) N1-2: R0 resection with lobectomy and mediastinal lymph nodes dissection (MLND) N0: R0 resection with lobectomy with or without MLND
  • Adjuvant treatment should start between 4 to 6 weeks after surgery
  • ECOG performance status 0-1
  • Weight loss during last 3 months should be less than 10%.
  • Normal hematologic, hepatic and renal function Neutrophil count > 1500 /microliter, Platelet > 100,000/microliter, Hemoglobin > 9 g/dL Bilirubin <=1.5 x upper limit normal, transaminase < 2.5 x upper limit normal Serum Creatinine <=1.5 mg/dL
  • Women in child bearing age should consent using contraceptive measures, and must have negative pregnancy test.

Who cannot join

  • Other malignant neoplastic disease within 5 years.
  • Neoadjuvant chemotherapy before surgery of lung cancer
  • Patients who will be treated with postoperative radiation.
  • Stage IIIB or IV lung cancer
  • Severe infection, or cardiorespiratory, hematologic illness
  • HIV positive cases
Show all 11Show fewer
  • Pregnancy or lactating women
  • Autoimmune diseases or those who receiving immune suppressive treatment
  • Symptomatic neuropathy > CTCAE grade 1
  • Those who consented other clinical trials within 3 months
  • Other significant medical conditions contraindicated to clinical trial

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • Kyungpook National University Medical Center

    Daegu, Kyungpook

  • Chungnam National University Hospital

    Daejeon

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 519-763

  • Pusan National University Hospital

    Pusan, 602-739

  • Kosin University Gospel Hospital

    Pusan

  • Korea university Guro hospital

    Seoul

  • Severance hospital

    Seoul

Other trials in South Korea

About this study

Official title: Efficacy and Safety of Pemetrexed Plus Cisplatin as Combination Chemotherapy for Post-operative Adenocarcinoma : Multi-center, Single Arm, Open-label, Phase Ⅱ Trial

Two-Year Disease Free Survival Rate of Stage IB~IIIA adenocarcinoma after Adjuvant Chemotherapy with Pemetrexed and Cisplatin will be assessed. A total of 106 patients will be recruited for 12 months, and followed for two years, thus the duration of study will be 36 months.

Read the detailed description

Primary endpoint : 2 year disease free survival

Secondary endpoints:

Overall survival, Frequency and severity of adverse events

Being tested
Pemebit, Cisplatin
Keywords
adenocarcinoma, lung, adjuvant chemotherapy, pemetrexed, cisplatin, surgery
Medical subject headings
Adenocarcinoma, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PemebitDrug

    Also called Pemetrexed

    500mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles

  • CisplatinDrug

    75mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles

Study groups in NCT02498860
Study groupRoleWhat they receive
Pemebit plus CisplatinExperimentalPemetrexed (Pemebit 500 mg/m2) plus cisplatin (75 mg/m2) every 3 weeks up to 4 cycles
Receives: Drug: Pemebit; Drug: Cisplatin

What is being measured

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

  1. Disease free survival rate

    Disease free survival time is measured from the date of enrollment to date of tumor recurrence.

    Measured: 2 year

Secondary outcomes (2)

  1. Overall survival

    Overall survival time is measured from the date of enrollment to date of death from any cause. Participants who are alive when the data lock or is lost to follow-up will have their overall survival time censored on the last date the participant is known to be alive.

    Measured: 4 year

  2. Adverse events

    adverse events using common terminology criteria for adverse events 4.0

    Measured: 4 months

Timeline

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

  1. First posted15 Jul 2015 (estimated)
  2. Study start1 Sep 2015
  3. Primary completion6 Feb 2018
  4. Study completion31 Jul 2021

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02498860
Sponsor's protocol ID
CNUHH-2015-7
Acronym
APICAL
Status last verified
Aug 2021
First submitted
13 Jul 2015
Last updated
6 Aug 2021
Results posted
No
Data monitoring committee
No

Publications

  • Kreuter M, Vansteenkiste J, Fischer JR, Eberhardt W, Zabeck H, Kollmeier J, Serke M, Frickhofen N, Reck M, Engel-Riedel W, Neumann S, Thomeer M, Schumann C, De Leyn P, Graeter T, Stamatis G, Zuna I, Griesinger F, Thomas M; TREAT investigators. Randomized phase 2 trial on refinement of early-stage NSCLC adjuvant chemotherapy with cisplatin and pemetrexed versus cisplatin and vinorelbine: the TREAT study. Ann Oncol. 2013 Apr;24(4):986-92. doi: 10.1093/annonc/mds578. Epub 2012 Nov 15.

    PubMed 23161898

  • Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzales-Larriba JL, Grodzki T, Pereira JR, Le Groumellec A, Lorusso V, Clary C, Torres AJ, Dahabreh J, Souquet PJ, Astudillo J, Fournel P, Artal-Cortes A, Jassem J, Koubkova L, His P, Riggi M, Hurteloup P. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006 Sep;7(9):719-27. doi: 10.1016/S1470-2045(06)70804-X.

    PubMed 16945766

  • Olaussen KA, Dunant A, Fouret P, Brambilla E, Andre F, Haddad V, Taranchon E, Filipits M, Pirker R, Popper HH, Stahel R, Sabatier L, Pignon JP, Tursz T, Le Chevalier T, Soria JC; IALT Bio Investigators. DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med. 2006 Sep 7;355(10):983-91. doi: 10.1056/NEJMoa060570.

    PubMed 16957145

  • Park CK, Oh HJ, Yoo SS, Lee SY, Lee SH, Kim EY, Lee SY, Choi J, Lee MK, Kim MH, Jang TW, Chung C, Oh IJ, Kim YC. Open-label, multi-center, phase II study of adjuvant pemetrexed plus cisplatin for completely resected stage IB to IIIA adenocarcinoma of the lung: APICAL trial. Transl Lung Cancer Res. 2022 Aug;11(8):1606-1618. doi: 10.21037/tlcr-22-183.

    PubMed 36090637

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemebit and Cisplatin in people with Adenocarcinoma and Lung Neoplasm, run by Chonnam National University Hospital at 7 sites in South Korea.

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 8 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 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. 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?

Disease free survival rate (time frame: 2 year). 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 NCT02498860, which also lists 4 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 6 Aug 2021.

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