# CONKO-005

Source: https://onco.cc/trials/conko-005/  
OnCo record `conko-005` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

CONKO-005 was the first adjuvant trial to add a targeted drug to chemotherapy after pancreatic surgery; six months of erlotinib with gemcitabine made no difference to the time before relapse (11.4 months in both arms) or to survival.

## Summary

CONKO-005 randomised 436 patients after R0 resection to gemcitabine 1,000 mg/m2 on days 1, 8 and 15 every four weeks with or without erlotinib 100 mg once daily for six cycles, aiming to lift median disease-free survival from 14 to 18 months. After a median follow-up of 54 months and 361 recurrences, median disease-free survival was 11.4 months in both arms and median overall survival 24.5 months with erlotinib against 26.5 months without; estimated survival at one, two and five years was 77, 53 and 25 percent against 79, 54 and 20 percent, and rash did not predict benefit. Together with the erlotinib arms of LAP07 and RTOG 0848 step 1 it closed the EGFR question in pancreatic cancer outside the licensed metastatic indication.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Also known as: CONKO 005
- Phase: 3
- Setting: R0-resected pancreatic ductal adenocarcinoma in Germany: six cycles of adjuvant gemcitabine with or without erlotinib 100 mg daily, with disease-free survival as the primary endpoint
- Sponsor: Charite University Medicine Berlin (CONKO study group)
- Enrolled: 436
- Result: Median disease-free survival 11.4 months with gemcitabine plus erlotinib and 11.4 months with gemcitabine; median overall survival 24.5 against 26.5 months.
- Outcomes: Disease-free survival: Adjuvant gemcitabine + erlotinib 11.4 months vs Adjuvant gemcitabine 11.4 months; Overall survival: Adjuvant gemcitabine + erlotinib 24.5 months vs Adjuvant gemcitabine 26.5 months

## Sources

- Sinn et al., CONKO-005 (JCO 2017): https://doi.org/10.1200/JCO.2017.72.6463
- Abrams et al., RTOG 0848 step 1: adjuvant erlotinib plus gemcitabine (Am J Clin Oncol 2020): https://doi.org/10.1097/COC.0000000000000633

## Connected records

- cancers: [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Resectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/resectable-pdac/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- drugs: [Erlotinib](https://onco.cc/drugs/erlotinib/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/)
- institutions: [Charité Universitätsmedizin Berlin](https://onco.cc/institutions/charite/)
- terms: [Pancreatic cancer: the failed and stopped programmes and why](https://onco.cc/terms/pancreatic-failed-programmes/)

---
JSON: https://onco.cc/api/v1/entities/conko-005.json